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Within UL Solutions we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Approved/Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brand, we have processes in place to identify and manage any potential conflicts of interest and maintain impartiality. UL Solutions is unable to provide consultancy services to EU MDD, MDR or IVDD Notified Body, UKCA MD Approved Body or MDSAP Customers.
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PFAS Testing, Validation and Advisory Services

We help manufacturers, retailers and suppliers align with evolving global standards and consumer requirements for per- and polyfluoroalkyl substances (PFAS).

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What are PFAS and why do they matter?

Per- and polyfluoroalkyl substances (PFAS) are a group of thousands of artificial substances used to make fluoropolymer coatings and products that resist water, dirt, oil, heat, stains and grease. They are widely used in textiles, food packaging, cosmetics, electronics and other applications. PFAS, also known as forever chemicals, are highly persistent in the environment and pose serious risks to human health.

Concerns about the impact of these toxic substances have led to public demand for action, as well as from governments and technical committees responsible for safety and environmental standards. In response, new chemical regulations have been introduced around the world to restrict and control the use of certain PFAS in specific applications.

For example, in the EU, PFAS, including Perfluorooctane Sulfonate (PFOS), Perfluorooctanoic Acid (PFOA), Perfluorocarboxylic Acid (PFCA), Perfluorohexane sulfonic acid (PFHxS), Undecafluorohexanoic acid (PFHxA), their salts and their related substances, are already regulated under Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Persistent Organic Pollutants (POP) legislation and the Substances of Very High Concern (SVHC) list.

There is a current larger proposal for restrictions that will cover all PFAS with specific exemptions and different dates of entry into force for specific uses and applications.

PFAS is defined as any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom without any hydrogen, chlorine, bromine or iodine attached to it.

In the U.S., due to the lack of federal regulations banning the use of PFAS in consumer products, many state legislatures are acting to help mitigate the use of these chemicals in various consumer products. Several states have already adopted policies prohibiting the intentional addition of PFAS to various consumer products. The states of Maine, Minnesota and New Mexico will prohibit the use of intentionally added PFAS in products without a current unavoidable use waiver, effective Jan. 1, 2032. Leading up to the all-product ban, Minnesota and New Mexico will institute reporting regulations for all products with intentionally added PFAS sold, offered for sale or distributed in the state(s). Minnesota’s reporting regulation begins July 1, 2026, while New Mexico’s begins Jan. 1, 2027. In addition to reporting, New Mexico will also require the labeling of products containing intentionally added PFAS beginning Jan. 1, 2027.

Staying aligned with evolving PFAS regulations 

Keeping pace with these new chemical regulations is critical for anyone bringing products to market. UL Solutions works with retailers, manufacturers and suppliers to simplify compliance — helping you interpret restriction lists, understand global requirements and reduce risk across your supply chain.

How UL Solutions can help

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Testing

Testing products for PFAS is complex — especially without a globally standardized list and differing restrictions between countries.

Our experts can evaluate your products against PFAS regulations in your target markets, helping you showcase compliance and build trust. Our global network of accredited laboratories provides advanced testing capabilities, including Total Organic Fluorine analysis and screening for over 200 individual PFAS compounds.

 

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Validation

UL Solutions offers validation to a threshold of 50 parts per million (ppm), a benchmark that helps demonstrate your commitment to reducing PFAS content in products and meeting stringent compliance expectations.

Why 50 ppm?

This threshold aligns with emerging global best practices and regulatory trends, signaling that your products contain minimal levels of PFAS. By validation to 50 ppm, you position your products as responsible, compliant and future-ready in a market increasingly focused on chemical transparency.

Benefits:

  • Independent, third-party verification of PFAS content below 50 ppm
  • Documentation to support compliance with retailer requirements and regulatory standards
  • Marketing advantage: Demonstrate to customers and stakeholders that your brand prioritizes health, safety and sustainability

 

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Advisory

Planning for market access starts with a strong compliance strategy. Our experts can help you build that foundation by creating a Restricted Substance List (RSL) tailored to your business — making it easier to manage evolving chemical requirements and prevent noncompliant products from reaching consumers.

We also provide training, guidance and ongoing support to help you prepare for upcoming PFAS restrictions and regulatory changes.

 

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