Overcoming the complexity of PFAS product regulations

One of the most dynamic and complicated aspects of per- and poly-fluoroalkyl substance (PFAS) regulation is the rapidly expanding set of initiatives focused on restricting PFAS in products.

The persistence, perceived toxicity, and diverse environmental transport pathways for PFAS, as well as the challenges and costs associated with managing PFAS in the environment, make it is easy to understand why initiatives attempting to control sources of PFAS have been prioritized in advocacy, policy, and regulation.

PFAS prevented from entering the environment in the first place can reduce risks and liabilities, and the need for subsequent management and environmental cleanup.

Why regulating PFAS is so complicated

Initiatives that attempt to help answer these questions with broad strokes and simplifications paradoxically exacerbate the challenges of regulatory compliance and product stewardship. Two of the most complex challenges are the varying and changing definitions of PFAS and identifying the points where PFAS may be entering the supply chain.

The presence of PFAS in products

With their oil resistance, water proofing, heat resistance, and lubricating and surface protection characteristics, PFAS have been used widely in products ranging from textiles to electronics, food packaging to paints, and cosmetics to firefighting foam.

PFAS can also be found widely in and on products where they are not a specific ingredient, since they may be present in lubricants or other products used on manufacturing equipment. They are also widely present in the environment around us in ‘background’ concentrations, meaning that air, water, and soil may also contribute to PFAS found on or in products.

The easily stated goal of managing and controlling PFAS in products quickly becomes complicated by questions as basic as: “Are the substances in my product classified as PFAS?” and “How is PFAS ending up in my product?”

Recent re-definitions of PFAS

PFAS are generically recognized as substances containing carbon chain backbones with all or most of the remaining bonding sites filled by the element fluorine; the carbon-to-fluorine bond is key to both functional and environmental characteristics.

However, refinement of this general definition in classifying individual chemicals as PFAS varies among jurisdictions.

In the US

While the generic description of PFAS covers thousands of compounds, the US Environmental Protection Agency (USEPA) has historically identified the specific chemicals, not classes of chemicals, that it is seeking to address. For example, PFOA and PFOS (two of the most common PFAS) have been subject to USEPA actions for over a decade. This specificity allows interested parties to test for and evaluate the relevant PFAS and to plan and manage compliance relatively clearly.

In November 2022, USEPA introduced an expanded PFAS definition in conjunction with listing PFAS as a group for certain regulatory purposes. The new definition captures substances with branched carbon chains and a group known as fluoroethers; both groups are widely used in products.

More significantly from the perspective of regulatory complexity, the broadened, non-specific definition makes determining which chemicals meet USEPA’s definition more challenging. Instead of a lookup table with unique chemicals listed, parties must rely on product stewards with substantial expertise in interpreting the structural elements and coded abbreviations used in the definition in order to determine which constituents might be considered PFAS under the expanded USEPA definition.

And internationally

In 2021, the Organisation for Economic Co-operation and Development (OECD) released an expanded definition of PFAS that also captures more branched substances and, interestingly, substances that are not typical PFAS structures until they are degraded in certain ways. The EU adopted essentially this definition in its recent proposed restriction of PFAS, discussed further below. To comply with this definition, product stewards must consider not only PFAS ingredients or content, but substances that could become PFAS subsequently if certain conditions existed.

Where are the PFAS coming from?

The varying and changing definition of what substances qualify as PFAS under different regulatory programs introduces the next major challenge: determining sources of PFAS in a product.

The same context and interpretation relevant for determining if a product contains PFAS as defined in regulation apply when the question is posed up the supply chain. Ingredient composition as provided by suppliers may not be sufficiently specific to determine whether PFAS pursuant to certain definitions are present. In many applications, PFAS content is below the threshold concentrations for being included on Safety Data Sheets, making these an uncertain basis for identifying sources from ingredients or raw materials.

In addition, asking a supplier whether PFAS are present in their product can yield uncertain information or a response that is accurate in only certain context or jurisdictions.

Unintentional PFAS presence

Beyond the complexities of identifying intentionally added ingredients that may be PFAS are the challenges of identifying PFAS that may be present as impurities in ingredients, byproducts of processing, transferred from packaging, or process aids from manufacturing steps. The widespread uses of PFAS in surface coatings, surfactants, cleaners, and lubricants provide potential points of entry for PFAS to be incorporated onto or into a product or ingredient from equipment or process aids during production. Transfer from these types of sources can be relevant since the concentrations of potential relevance in regulatory programs for PFAS may be extremely low (e.g., less than one part per billion).

PFAS regulation around the globe

In the US, state-level initiatives to control PFAS in commerce are now routinely on legislative dockets. A majority of states have enacted some type of controls or limitations, and these are not harmonized with each other.

At the national level, three of the most consequential USEPA compliance programs: TSCA (chemicals), FIFRA (pesticides), and CERCLA (Superfund), have initiated updates that pertain to PFAS in products or containers – and these updates are also not harmonized.

The diversity of emerging requirements necessitates that affected companies expend a substantial effort for compliance with reporting, supply chain investigation, and content limitation provisions.

The EU’s chemicals regulation program is REACH (Restriction, Evaluation, Authorization of Chemicals). The restriction portion, which is applicable to many different product types, is being used as a mechanism to ban the use or importation of PFAS-containing products.

Broad prohibitions on manufacture or distribution of PFAS-containing products in the EU were included in a proposed restriction published in February 2023. In this proposal, the EU also breaks new ground by intentionally expanding the applicability to cover articles and mixtures incorporating fully polymerized materials, restricting, for example, plastic tubing itself, not just PFAS used in its manufacture. Countries that match or follow REACH, including the UK, will end up with similar control approaches and associated challenges.

How companies can comply with regulations

Compliance with PFAS product regulation will require more effort and coordination with suppliers than is necessary for other chemicals due to the need for careful evaluation of feedstocks and ingredient production. Auditing steps will need to go beyond the typical levels and consider factors such as production equipment maintenance and routine cleaning, painting, and other products used in manufacturing areas.

How Ramboll can help

We work with companies around the world, helping them navigate and comply with chemicals regulations. From advice on obligations and strategic planning to technical analysis, support and troubleshooting, we provide comprehensive compliance services tailored to meet our clients’ very different needs around PFAS.