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Recently, there has been much discussion about per- and polyfluorinated alkyl substances (PFAS) contamination in water sources, soil and sediment and, of late, contamination of food due to PFAS in food packaging. PFAS chemicals in food packaging can migrate into food, especially when food containers, packaging and wrappers that contain PFAS are exposed to fatty, salty, or acidic foods.

PFAS are also known as “forever chemicals,” as this class of man-made chemicals, which contains over 9,000 known PFAS compounds, are resistant to biodegradation. In summary, they do not easily break down in the environment, and thus have been shown to bioaccumulate – or build up – in humans and wildlife with exposure. Although the US Food and Drug Administration (FDA) has provided guidance regarding of PFAS in food contact applications, the presence of these forever chemicals in food packaging is particularly concerning, as small amounts of PFAS in the body can lead to serious health problems. Certain PFAS have been linked to cancer, suppressed immune function, and reproductive toxicity, including birth defects and infertility, developmental toxicity, and preeclampsia in pregnant women.

Authorized uses of PFAS in food contact materials

The FDA has authorized four general application categories for PFAS in food contact materials:

• Non-stick cookware coatings;
• Gaskets, O-rings and other resin-based components of food processing equipment;
• Processing aids for manufacturing other food contact polymers, and
• Paper and paperboard food packaging to prevent grease from leaking through packaging.

In order for the FDA to authorize food contact substances for market entry, the Agency must find that the data provided demonstrates there is a reasonable certainty of no harm under the intended conditions of use. The FDA can also revoke food contact authorizations when warranted. The ability of PFAS chemicals to migrate into food and contaminate food products is dependent upon multiple factors, including the molecular structure of the substance, how the product is manufactured and its intended use.

When considering potential sources of contamination from paper and paperboard food packaging that contain PFAS chemicals, it is important to understand how PFAS are applied to the paper packaging. According to the FDA, PFAS molecules are attached to other non-PFAS polymerized molecules as smaller “sidechains” to create the grease-proofing agent that is applied to the paper and paperboard packaging at lower temperatures. These lower temperatures do not allow for the removal of residual, smaller PFAS molecules that can contaminate food products. Consequently, under certain conditions, the smaller PFAS “sidechain” can detach from the polymerized molecule, migrating into and contaminating food.

Voluntary phase-out of certain PFAS-containing food contact materials

In 2021, three manufacturers of food contact substances agreed to an FDA-led voluntary phase-out of specific short-chain per- and poly-fluoroalkyl substances (PFAS), that contain 6:2 fluorotelomer alcohol (6:2 FTOH), used as food contact substance grease-proofing agents in some paper and paperboard food packaging. A three-year phase out of sales of these compounds in the US marketplace began in 2021, with the expectation that after the three-year period, it could take up to an additional 18 months for the stock of products currently on the market that contain 6:2 FTOH to be exhausted.

The FDA granted authorization to four companies for the use of these short-chain grease-proofing agents through the Food Contact Notification (FCN) process. As discussed, three companies have agreed to a voluntary phase-out, and the fourth manufacturer stopped sales of food contact substances containing 6:2 FTOH in 2019. At the time the FCNs for short-chain PFAS became effective, data demonstrated they were a safe alternative to long-chain PFAS. Since that time, the Agency has conducted post-market scientific reviews and found that rodent studies have reported biopersistence of 6:2 FTOH, leading to the conclusion that the chemical may also potentially persist in humans after consuming food which has been exposed to the compound. While additional studies are needed to better understand the risk to human health, the phased removal of these materials from the market limits the potential for supply chain disruption while addressing the potential public health risk.

The regulation of PFAS in food packaging and food contact materials

Safety assessments are conducted by the FDA when detectable levels of PFAS are found in foods, to evaluate whether the levels of PFAS present pose a potential concern to human health. Several factors are considered, including whether an action level of tolerance has been established, how much of a specific food is typically consumed, the level of contamination detected, and the toxicity of the contaminant. Per the FDA, the Agency uses different resources for toxicological reference values (TRVs) for PFAS, and recently started using the finalized minimal risk levels (MRLs) in the May 2021 from the Toxic Substances and Disease Registry, as well as a , also finalized in 2021.

States are taking action to regulate acceptable limits of PFAS in food packaging and food contact materials. On October 5, 2021, California Assembly Bill (AB) 1200 was signed into law, banning all plant fiber-based food packaging containing intentionally added PFASs. The law also bans plant fiber-based food packaging that contains PFAS present at levels exceeding 100 parts per million total fluorine. It is important to note this legislation will not take effect until January 1, 2023. There is much speculation that with the precedent now set by the state of California, further legislation and regulation of PFAS in food packaging, including trace limit levels, will soon follow.

Measuring PFAS in food and food packaging with FDA analytical methodology

Since 2012, the FDA has been refining an using liquid chromatography-tandem mass spectrometry (LC-MS-MS) for the testing of food matrices for the presence of 16 PFAS analytes. The methods were expanded and validated in 2019, and further optimized in 2021 for processed foods. In spring/summer 2022, revised methodology will be published, allowing for the detection of four additional PFAS compounds, including PFUda, PFDoA, PFTrDA, and PFTeDA, extending the method from 16 to 20 types of PFAS.

Element’s teams of highly knowledgeable scientists have the experience and expertise to apply the FDA PFAS testing methodology to a variety of samples, including food and food packaging materials. With deep experience in analytical method development and validation, Element can revalidate the existing FDA method for paper and paperboard food packaging material.

PFAS contamination testing is critical to preventing PFAS exposure

PFAS compounds repel oil, grease and water, and are a key component of fluoropolymers, which are used in the manufacture of non-stick cookware. As discussed, PFAS can be found in food contact materials, including microwave popcorn bags, grease-proof containers, fast food wrappers, and pizza boxes. With many potential sources of exposure and contamination, implementing a robust PFAS testing strategy with a validated analytical method is key to identifying and preventing PFAS contamination. Furthermore, with state-led legislation on the horizon, food packaging manufacturers looking to stay ahead of upcoming policies and legislation will need the support of a consultative, proven PFAS testing lab to ensure food contact and packaging materials comply with regulations. Element’s PFAS testing lab offers industry-leading analytical solutions, including LC-MS/MS PFAS testing per FDA analytical methods validated for several food matrices. Our highly skilled teams of consultative scientists deliver results that meet or exceed current regulatory limits.

With the capacity and ability to analyze a wide range of sample matrices, ranging from consumer products, tissues, biosolids, emulsions and fluoropolymer dispersions, to food, feed and agricultural products, in addition to highly sensitive PFAS testing methodology, Element is a leader in comprehensive PFAS testing solutions. If you are ready to start the conversation about partnering with Element to implement a PFAS testing program or to discuss PFAS contamination testing, connect with an expert today.