Per- and polyfluoroalkyl substances (PFASs), also referred to as FluoroTechnology or fluorinated chemistries, provide strength, resilience and durability to an array of products in various sectors. The food industry is one such sector. PFASs are used in a variety of applications relevant to food contact applications, including food packaging.
Food packaging protects the quality and integrity of food, extends shelf life, and helps in the hygienic transportation and storage of food. Certain PFASs, specifically fluorotelomer-based products, are used to prevent oil and grease from seeping through food packaging materials. This is especially useful for paper and paperboard packaging used with high-oil content and high-grease content foods, such as popcorn bags, food wrappers, pizza boxes and disposable plates. Treatment prevents oil and grease from leaking through food packages onto clothing, skin, furniture or car interiors; increases the shelf life of some foods; and reduces the amount of plastic packaging required. In heated food applications, such as popcorn bags, the treatment prevents the migration of hot oil through the package to help prevent burns.
Another category of PFASs, known as fluoropolymers, are specialty plastics used in repeat-use food contact applications such as tubing and hoses in soda and ice cream dispensers, and components of food processing equipment such as gaskets, sealants, and filters.
The use of PFASs in food contact applications has received a great deal of attention in recent months. The following information provides clarity on the issue.
The major manufacturers of fluorinated chemistries in the U.S., Japan, and Europe have worked with regulators around the world, testing their products to ensure they meet applicable health and safety standards for use in food packaging materials and other food contact applications. In the U.S., for example, chemicals used in food packaging and other food contact applications (so-called “food contact substances”) are regulated by the U.S. Food and Drug Administration (FDA) as “food additives.”
Before a new food contact substance can be sold or distributed in U.S. commerce, it must be reviewed by the FDA. Such use is only permitted if the agency concludes that there is sufficient scientific data to demonstrate that the substance is safe for its intended use in food contact applications such as packaging. In order to demonstrate that a food contact substance is safe for its intended use, FDA requires that chemical manufacturers submit extensive test data and scientific information regarding1:
- The chemical composition of the food contact substance, including all impurities and potential degradation products under intended conditions of use;
- The levels of substances that may be released from the food contact substance under intended use conditions and the resulting potential dietary concentrations of those substances;
- Toxicity data (and any other relevant health and safety data) on the substance itself, and on all impurities, degradation products and other components of the food contact substance.
FDA can withdraw its acceptance of a food contact substance at any time if available data no longer demonstrate that the food contact substance is safe for its intended use. If this occurs, the food contact substance can no longer be distributed in commerce for food contact use.2
FDA has determined that PFASs currently used in food packaging and other food contact applications are safe for their intended use.3
Older vs. Newer Fluorotelomer-based Chemistries
A decade ago, major manufacturers started working with U.S. Environmental Protection Agency (EPA) and other regulators to globally phase out PFASs of concern – PFOA and long-chain fluorotelomer-based products. The long chain PFAS phase-out by major manufacturers is now complete. To support that phase-out and still ensure the valuable benefits of PFAS chemistry are available for the applications and products that rely on them, these same manufacturers worked, in cooperation with regulators, to develop innovative, well-studied alternatives, based on “short-chain” fluorotelomer-based polymeric products.4
It is well known and generally accepted that the polymeric products used in these applications do not represent significant risk to health or safety. The degradation products of these short-chain fluorotelomer-based polymeric products have significantly improved health and safety profiles compared to the previous long-chain fluorotelomer-based products. For example, the degradation products of short-chain fluorotelomer-based polymeric products used in food packaging are less toxic and are much more rapidly eliminated from the body.
In 2011, the major manufacturers of PFASs used in food packaging voluntarily ceased use of certain long-chain fluorotelomer-based coatings.5 All remaining use of long-chain based products in food packaging was revoked by the FDA on January 4, 2016.6
In this 2016 revocation notice, FDA recognized the distinction between now-banned long chain fluorotelomer-based products and the current short-chain fluorotelomer-based products in stating:
“The toxicological profile of extended perfluorinated alkyl chains varies with chain length: On a general basis, those with extended perfluorinated alkyl chains greater than or equal to eight carbons in length [long chain] demonstrate biopersistence in chronic feeding studies, while those with extended perfluorinated alkyl chains less than eight carbons in length [short chain] do not.”7
A study published in the February 2017 edition of the Environmental Science & Technology Letters has driven much of the recent news coverage on the use of PFASs in food packaging. In the study, researchers tested samples of food packaging materials from fast food restaurants for total fluorine, based on the Danish organofluorine limit, which considers all PFASs to have the inherent hazards of PFOA and aggregates all organofluorine compounds as PFOA equivalents.8 The scientific literature does not support the assumption of PFOA-equivalent inherent hazard of all PFASs, nor the cumulative organofluorine limit. Importantly, total fluorine measurement is not indicative of the use or level of PFASs.
The researchers conducted further testing specifically for PFASs on 20 sample materials and noted that some samples contained PFOA. Because the samples were collected in 2014 and 2015, before the 2016 FDA action to revoke the use of long chain fluorotelomer-based products, it is not surprising that PFOA may have been detected in some of the products. Further, it is not surprising PFASs would be detected in food packaging, as the current short-chain PFASs are used to improve the performance of the packaging and have been accepted by FDA for use in food contact applications.
Non-fluorinated alternatives have not been found to provide comparable performance properties provided by PFASs. Recent commentary has noted that some food packaging has not been treated with PFASs, and concluded that non-fluorinated treatments are available. This observation fails to recognize the wide range of performance needs and the fact that some food packaging is simply not treated with PFASs because the packaging is not expected to provide oil- and grease-resistance.
In selecting packaging materials that provide oil- and grease-resistance, recyclability is another important consideration. Treatment of packaging with PFASs does not affect the ability of the packaging to be recycled. Many other alternatives can prevent the packaging from being recycled or from being compostable.
Typically, fluoropolymers used in food contact applications are of sufficient molecular weight that they are not bioavailable and they are extremely stable; therefore there is a broad consensus that they do not present a significant risk to human health or the environment.
Food Packaging Fact Checker
1See 21 U.S.C. § 348(h)(1) ; 21 C.F.R. §170.100. See also, FDA, Guidance for Industry Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations (December 2007); FDA, Guidance for Industry Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations (April 2002).
2See 21 C.F.R. §170.105(a)
4 In the US, this phase-out was conducted pursuant to EPA’s PFOA Stewardship Program. See https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/and-polyfluoroalkyl-substances-pfass-under-tsca
6See Indirect Food Additives: Paper and Paperboard Components, 81 Fed. Reg. 5 (Jan. 4, 2016).
7Id. at 7.
8Fluorinated substances in paper and board food contact materials (FCM); Danish Veterinary and Food Administration, Ministry of Environment and Food of Denmark: Glostrup, Denmark, 2015.