In recent years, few substances have received as much attention as per- and polyfluoroalkyl substances (PFAS). This name covers a family of durable, synthetic fluorocarbons that are persistent, bioaccumulative, and toxic. Some estimates include over 12,000 different substances in the PFAS family.

Due to their tight chemical bonds, these substances have difficulty breaking down over time, which has resulted in them being nicknamed “forever chemicals.” These chemicals resist degradation in the environment and accumulate in the body — studies have shown potential adverse human health effects from exposure to some PFAS. These chemicals may be linked to health conditions like:

  • Increased risk of thyroid disease
  • Increased blood cholesterol levels
  • Decreased vaccine response
  • Decreased fertility in women
  • Increased risk of high blood pressure and preeclampsia
  • Lower infant birth weight

Due to their long-lasting and accumulative nature, these substances are increasingly subject to a variety of global regulations, including numerous national and state-level requirements in the U.S. and EU.

While initially many PFAS-related regulations targeted specific substances (e.g., perfluorooctane sulfonic acid [PFOS] and perfluorooctane acid [PFOA]), increasingly regulations are pointing to the whole family for new reporting obligations and eventual restrictions. With more of these regulations on the horizon, along with multiple class action lawsuits against PFAS in consumer products, manufacturers must understand what’s at stake and how to mitigate market access loss, public perception concerns, risks to their customers, and other business impacts, including manufacturing operations and insurance liability.


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Products With PFAS

PFAS substances provide many desirable material characteristics. They are widely used in applications where resistance to water, oil, and heat is required. Non-stick and stain-resistant surfaces also frequently utilize PFAS chemicals. Their applications are seemingly endless and as such, they have a widespread presence in a variety of products. PFAS are found in products like:

  • Fast food packaging and wrappers
  • Pesticides 
  • Dental floss
  • Cosmetics
  • Water resistant clothes
  • Furniture
  • Non-stick cookware
  • Fire-fighting foam

U.S. Regulations

TSCA

In June 2021, the U.S. EPA proposed Section 8(a)(7) to the Toxic Substances Control Act (TSCA), which requires manufacturers to report on their use of PFAS going back to 2011, specifically regarding PFAS uses, volumes, disposal, exposures, and hazards. This requirement also applies to imported materials. 

While the reporting obligation is still a proposal, the finalized rule is expected by the end of 2022. The EPA has identified at least 1,364 PFAS chemical substances and mixtures that are potentially subject to reporting under the final rule.

In addition to the reporting obligation, there is no “de minimis” threshold that would exempt smaller companies or those who use PFAS chemicals in small amounts.

Other U.S. Regulations

In August 2022, the EPA proposed the designation of two types of PFAS as “hazardous substances” under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), also known as “Superfund.” The EPA announced that it plans to designate PFOA and PFOS as “hazardous,” which would impose new reporting obligations. This would also give the EPA authority to force responsible parties to investigate and clean up contamination or pay to remediate contaminated sites.

This could increase legal liability for companies that use PFAS in their operations or products, including those that import these substances on their own or in articles (specifically mentioned in the proposal). Future listings of other PFAS chemicals, including hexafluoropropylene oxide dimer acid (HFPO-DA, also referred to as “GenX”) and perfluorobutane sulfonic acid (PFBS), are anticipated.

Additional State-Level Legislation

More than 30 states have current or proposed legislation regulating PFAS substances, including some that look similar to the proposed TSCA reporting requirements. A sample of those state regulations and activities include:

    • California: AB 2247 requires manufacturers to annually submit details to a public database about PFAS-containing products or components sold in or imported into California within the past calendar year. Recent negotiations in the legislature moved the compliance deadline to July 2026. The bill now awaits the governor’s signature. Separately but not surprisingly, California Proposition 65 also already includes several PFAS chemicals.
  • Maine: As of January 2023, Title 38 §1614 requires that manufacturers report products containing intentionally added PFAS substances. It also bars the sale of specific products containing PFAS.
    • New Hampshire: HB 1589 prohibits the sale of intentionally-added PFAS to provide a specific characteristic, appearance, or quality or to perform a specific function. This also includes any degradation by-products of PFAS. This bill would also require warning labels on products containing PFAS.
  • Colorado: HB22-1345, which was signed into law in June 2022, established a regulatory scheme, collecting information from product manufacturers regarding the use of PFAS chemicals in their products. It also phases out the sale or distribution of intentionally added PFAS chemicals.
  • Wisconsin: The Attorney General is filing lawsuits against companies suspected of causing PFAS contamination. 

Canadian Regulation

Canada is considering amending its Prohibition of Certain Toxic Substances Regulations. The proposed regulations would prohibit the manufacture, sale, use, and import of PFOS, PFOA, and long-chain perfluorocarboxylic acids (LC-PFCAs).

EU Regulations

REACH

The Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) Regulation will restrict PFCAs from February 2023 as part of the Annex XVII Restricted List. Restrictions have been proposed for both perfluorohexane sulfonic acid (PFHxS) and perfluorohexanoic acid (PFHxA). Moreover, all PFAS used in firefighting foams have been proposed for restriction.

Two groups of PFAS are already on the REACH SVHC list — GenX and PFBS. Five countries are also preparing a restriction proposal, expected in January 2023, that will cover a wide range of PFAS uses.

Furthermore, five countries are preparing a restriction proposal to cover a wide range of PFAS uses, expected in January 2023.

Additional EU Regulations

  • The Stockholm Convention has included PFOS since 2009 and is currently restricted under Persistent Organic Pollutants (POPs) Regulation. PFHxS and PFCAs are being considered for inclusion in the Stockholm Convention. Additionally, PFOA has been banned under POPs Regulation since 2020.
  • The Classification, Labeling, and Packaging (CLP) Regulation already has multiple PFAS in scope, including PFOA, ammonium perfluorooctanoate (APFO), perfluorononanoic acid (PFNA), and perfluorodecanoic acid (PFDA). Perfluoroheptanoic acid (PFHpA) is under evaluation.
  • The Drinking Water Directive includes a limit of 0.5 μg/l for all PFAS.

Current Business Risks

Current and future PFAS regulations present manufacturers with a host of risks, including:

Operational risk

  • Changes to substances that you use in your manufacturing process could drive capital investments for new equipment.
  • Last-time buys may be required due to material obsolescence.
  • Employee and transportation safety requirements may increase as substances are reclassified as “hazardous.”

Product Design

  • New and existing regulations may impact market access for products containing PFAS. Products being sold today may not be able to be sold in the future.
  • Obsolescence of materials using PFAS may drive redesign and requalification/recertification.

Reporting Obligations

  • Many regulations increasingly require manufacturers to register and report on substances used in their products and operations, or to disclose their presence to customers.

Liability

  • Insurers are asking if companies are using PFAS in operations or products. Expensive obligations for site clean-ups in the future may fall back on manufacturers.

How to Mitigate Your Risks

As the PFAS regulatory landscape grows and encompasses more chemicals, it’s vital to take action now, proactively, rather than waiting. There are a few ways you can do this.

    1. Understand the data you already have. With it, you can make informed decisions about where your operational risks are hidden, how you may be affected by product design and reporting obligations, and what your liability is. Several of the most commonly restricted PFAS are already included in regulations — for example, EU REACH, EU POPs, and California Proposition 65.
  • Evaluate where you need more data. Figure out if you have blind spots, or if there are areas where you need more information before taking action. It’s important to understand where the commonly-associated PFAS characteristics are in your materials and products to identify your highest areas of risk and need for detailed information (e.g., water-proofing materials).
  • Understand reporting obligations under the new legislation. Failing to report can often lead to additional risks, like fines and market access loss. Take the time to understand what is required in the markets where you sell your products, and what the future landscape looks like, so you can be prepared to meet reporting obligations.
  • Redesign where needed. It’s better to proactively redesign now than to scramble once new regulations are passed — or existing ones are strengthened. Changing materials may impact other product compliance obligations or require recertification.
  • Plan for the future, including all PFAS chemicals. With so many different substances included under the PFAS banner, it’s important to plan ahead and incorporate all PFAS substances into future considerations.

Assent Makes This Easier

Keeping track of pending legislation, global regulatory requirements, and compliance niceties isn’t just one person’s full-time job — it requires a knowledgeable and dedicated team. 

With Assent’s Regulatory and Sustainability Experts team, you can trust that you will have all the regulatory insights you need, allowing you to see deep into your supply chain, maintain market access, and stay on top of new compliance requirements.

If you would like to learn more about how Assent can help you mitigate risks, including those related to PFAS regulations, contact us at info@assent.com.

Dr. Bruce Jarnot
Senior Manager, Product Compliance

Bruce is a board certified toxicologist with over 30 years of industry experience managing product safety and global materials compliance programs with large organizations,  Read More

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