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Overview

PFAS Compliance Guidance on Risk Assessment for Manufacturers

Per- and polyfluoroalkyl substances (PFAS), also known as “forever chemicals”, in your parts or supply chain carry a lot of risk. If you don’t have a PFAS compliance or PFAS risk management program in place, you could face:

  • Parts in your supply chain suddenly being unavailable (PFAS obsolescence)
  • Noncompliance with numerous PFAS regulations or bans, including the Toxic Substances Control Act (TSCA), California Proposition 65, and the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation
  • Legal liability risks, including lawsuits related to health impacts or product sustainability claims
  • Damage to your bottom line as customers choose PFAS-free products

It can be difficult to know if PFAS is in your supply chain: You might not be adding PFAS to your products, but suppliers may be. In addition, you might have equipment or machinery that requires PFAS to properly function, like PFAS-treat o-rings.

Watch the video to learn more.

 

 

See PFAS Requirements by State

PFAS Compliance Requirements Are Evolving

New regulations are cropping up, and current regulations are expanding, either broadening pfas reporting definitions to include more substances, or outright banning them. It’s important to start collecting information now because it will take substantial time to collect all the data you need for your PFAS solution.

Take proactive compliance steps like:

  • Identifying PFAS in your supply chain
  • Staying up to date on the latest regulations
  • Redesign where needed
  • Plan for the future

Latest Tools and Resources for PFAS Compliance

Prepare and scope your PFAS risks with our latest guides and resources.

Guide
PFAS Scoping Guide

Are you in scope of PFAS reporting requirements? Check out our scoping guide to evaluate your risks and ensure regulatory complian …

PFAS
eBook
The PFAS Handbook: The Ultimate Guide to Identifying & Mitigating PFAS Risks in Your Supply Chain

Step by step, this handbook will help you understand, identify, and mitigate the risks of PFAS in your supply chain, with expert g …

PFAS, Product Compliance, Prop 65, REACH, TSCA
Guide
Facing Change: Emerging PFAS Risks & Parts Obsolescence for Manufacturers

The world of manufacturing is rapidly changing, and the landscape of per- and polyfluoroalkyl substances (PFAS) is a big part of t …

ESG, Product Compliance, Supply Chain Sustainability
Infographic
Every Minute Matters: The PFAS Reporting Timeline

This infographic shows you several state and federal PFAS reporting deadlines so you can be prepared in time to stay PFAS complian …

PFAS

Frequently Asked Questions About PFAS Compliance

Research and regulations around PFAS are constantly being updated, making it hard to keep up. Here are some of the common questions about PFAS compliance from Assent’s PFAS experts.

How Many PFAS Are Tracked?

The PFAS family contains thousands of chemicals that are actively monitored or regulated, and there are many others no longer in use or that may not be monitored at the moment. In addition, because PFAS are synthetic, there is no ceiling to the number of PFAS that could hypothetically exist in the future without regulatory intervention.

A number of different regulatory bodies and NGOs around the globe track PFAS, and because each of them uses a different formal definition of what are PFAS chemicals, the number of PFAS chemicals can differ between regulations. There is no official list or number of PFAS chemicals. This can make it difficult for businesses and consumers to understand their responsibilities and restrictions while using PFAS.

For instance, the Organisation for Economic Co-operation and Development (OECD) maintains a list of over 4,700 PFAS substances. The U.S. Environmental Protection Agency (EPA) identifies over 16,000.

Rather than focusing on the total number of PFAS, manufacturers should identify which PFAS are regulated or restricted (or are being considered for future regulation) in their relevant markets.

What Are the Most Common PFAS

The PFAS family of chemicals contains substances that are often used in the manufacture of industrial and consumer goods. Here are some of the more common ones and just a few examples of what the PFAS is used for (note that these substances may have several uses beyond what’s listed here):

  • Fluorinated ethylene propylene (FEP): A flexible and chemically-resistant copolymer that is mainly used as a film for computer wiring and cables.
  • Fluoroelastomers: A synthetic rubber with oil and grease resistance, good temperature resistance, and strong chemical and acid resistance. It is often used for o-rings and seals in aerospace, automotive, and industrial manufacturing facilities.
  • GenX™: The trademarked, popularized name for the ammonium salt of hexafluoropropylene oxide dimer acid (HFPO-DA). It also refers to the group of chemicals used to manufacture it. Used as a replacement for PFOA for manufacturing other fluoropolymers.
  • Perfluorooctanoic acid (PFOA): A byproduct of fluoropolymer production; used as a surfactant in chemical processes and in manufactured goods.
  • Perfluorooctanesulfonic acid (PFOS): A stain-repellent commonly used in fabric protectors.
  • Polychlorotrifluoroethylene (PCTFE): A water-repellent chemical commonly used in films to protect against moisture. For example, it is used in pharmaceutical packaging and LCD panels.
  • Polytetrafluoroethylene (ePTFE): A hydrophobic and oleophobic (oil-repellent) PFAS useful for medical accessories like face masks, wound-care, and ostomy bags.
  • Polytetrafluoroethylene (PTFE): A hydrophobic (water-resistant) PFAS that is non-wetting and resistant to high temperatures. Primarily used for its non-stick properties.
  • Polyvinyl fluoride (PVF): A PFAS mainly used in flame-resistant coatings. Commonly found in airplane interiors, automobiles, metal sheeting, and raincoats.
  • Polyvinylidene fluoride (PVDF): A specialty plastic that is resistant to solvents, acids, and hydrocarbons. Widely used across numerous industries.
What Are the top North American PFAS Regulatory Risks?
  • TSCA: The Environmental Protection Agency (EPA) roadmap for PFAS, including a  proposal requiring PFAS reporting going back to 2011. The final rule is expected to include 1,300+ substances.
  • 30+ states have created or proposed legislation regulating PFAS substances, including the state of Maine, which will require reporting of all products containing PFAS beginning in January 2023.

Check out Assent’s page covering PFAS reporting and state requirements list here to learn more.

What Are the top EU PFAS Regulatory Risks?
  • REACH, POPs, and the EU MDR restrict many PFAS.
  • C9-14 PFCAs will be restricted through REACH in 2023 as part of the Annex XVII Restricted List.
  • Five countries are preparing a REACH restriction proposal to include up to 4,700 PFAS chemicals, which is expected in 2023 and would take effect as early as 2025.
What Are PFAS Used For?

PFAS are widely used across various industries to achieve certain product benefits or allow certain manufacturing processes to take place. Because of their strong chemical bonds, they are resistant to water, stains, grease, and high temperatures. Businesses looking to determine what are PFAS used for in their processes should identify products or materials that have properties commonly associated with PFAS :

  • Non-stick
  • Electrical insulation
  • Flame-retardant
  • Thermal stability/heat resistance
  • Chemical resistance
  • Water-repellent
  • Anti-fogging
  • Oil- and stain-repellent
  • Ultraviolet resistance

In addition, the durability of PFAS makes them desirable in industrial sectors — including aerospace, automotive, construction, and electronics — and they play a critical role in the production of components that must withstand challenging environments.

How Do PFAS Chemicals Affect Human Health?

The same qualities that make PFAS so durable and resistant to heat and degradation also mean that PFAS do not break down over time and accumulate in the soil and drinking water, often bioaccumulating in the human body. In fact, according to national health authorities in the U.S., approximately 97% of Americans have PFAS in their bloodstreams. 

Studies have shown PFAS may have adverse human effects. They could lead to health conditions such as:

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

According to current research from the EPA, PFAS exposure can take place through many different routes:

  • Drinking water contaminated with PFAS
  • Eating certain foods that may contain PFAS, such as fish or dairy products
  • Breathing air contaminated with PFAS
  • Using products made with PFAS or that come in packages made with PFAS
  • Swallowing dust or dirt that contains PFAS
  • Working in environments that use PFAS, including chemical manufacturing or firefighting, and using PFAS chemicals
Why Are Governments Concerned About PFAS?

Regulators like the EPA and the European Chemicals Agency (ECHA) are increasingly concerned about PFAS. They are present in water sources, soil, and air, and in consumer and industrial products. They are also commonly used in manufacturing. This makes it difficult to avoid PFAS, so there is a high exposure rate for the everyday consumer and worker. 

Their persistent nature also makes PFAS difficult to remove from soil and drinking water, with traditional water-filtration technologies proving ineffective at mitigating PFAS contamination. However, there are a number of filtration methods that have been found effective by the EPA, including activated carbon treatment, ion exchange treatment, and high-pressure membranes.

Several lawsuits have been led by U.S. state and municipal governments against PFAS manufacturers over drinking water contamination. In addition, the EPA finalized the National Primary Drinking Water Regulation that sets PFAS contamination limits for six types of PFAS in drinking water.

On April 17, 2024, the EPA also classified thePFOA and PFOS as “hazardous” under the U.S. Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), also known as Superfund.

For more information on PFAS regulations, visit our PFAS reporting and state requirements page.

Gaining Visibility Into Where PFAS Are Used in Supply Chains

As consumer and regulator scrutiny of PFAS grows, manufacturers must understand where PFAS are found in their parts, products, and supply chains.

Gaining visibility into the use of PFAS within their supply chains is crucial for manufacturers, primarily to ensure compliance with evolving regulations and to mitigate potential health and environmental impacts, and to avoid other business risks. Understanding what are PFAS used for in products, and knowing what are PFAS can help manufacturers anticipate supply chain factors that could affect their operations or necessitate costly reformulations of products. Furthermore, with increasing consumer awareness, manufacturers that demonstrate proactive management of PFAS may gain reputational benefits and competitive advantage as market trends shift towards transparency and sustainability.

Manufacturers can gain visibility into their PFAS use by engaging with their suppliers and surveying them about their PFAS use in the parts they provide. They should also familiarize themselves with the definition of what are PFAS used by the regulators in the markets they do business in.

How Assent Helps Manufacturers Identify PFAS Use

Assent simplifies the complex task of tracking and managing PFAS use in the supply chain. We automate supplier survey campaigns and improve the reporting process using a comprehensive software platform and secure supplier portal.

With our PFAS solution, manufacturers can gather and review detailed information about the components and materials suppliers provide. Real-time dashboards and reporting features deliver invaluable insights into the presence of PFAS in products, helping businesses meet their regulatory requirements and make informed decisions about sourcing and product development.

Assent also provides unmatched regulatory expertise into where PFAS are used. Our team of knowledgeable professionals stays current with the evolving landscape of global PFAS regulations, providing guidance to manufacturers navigating complex compliance channels. Through training, solution updates, and strategic program guidance, Assent ensures that manufacturers are equipped with the industry best practices they need to handle regulatory changes as they happen.

Discover Assent’s PFAS Software

Identify PFAS in your supply chain and set yourself up for success using Assent PFAS software.