The widespread use of PFAS materials and their persistence have rightfully made them the target of much scrutiny. But banning the entire class of PFAS would be disruptive without any basis in science or good public policy, according to Mark Jeffreys, CEO of 4Sight. Here, he critiques the proposed ban across the entire class of PFAS chemicals and offers a more deliberate, evidence-based approach. While it does not necessarily reflect the opinions of C&T, we offer it for your consideration and investigation. -Editor
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The widespread use of PFAS materials and their persistence have rightfully made them the target of much scrutiny. But banning the entire class of PFAS would be disruptive without any basis in science or good public policy, according to Mark Jeffreys, CEO of 4Sight. Here, he critiques the proposed ban across the entire class of PFAS chemicals and offers a more deliberate, evidence-based approach. While it does not necessarily reflect the opinions of C&T, we offer it for your consideration and investigation. -Editor
See archived: What California’s PFAS Law Could Mean for the Cosmetics Industry Nationwide
"When the movie 'Dark Waters' debuted in 2019, it awakened the world to per- and polyfluoroalkyl substances (PFAS) or so-called 'forever' chemicals and their impact on human health and the environment," Jeffreys writes.
"Now, almost every day there are headlines about a new lawsuit or settlement, often in the billions, and new evidence of a disease associated with one of these ingredients. As a result, multiple regulatory agencies from the European Chemical Agency to several U.S. states are proposing varying degrees of bans."
Restrictions in Cosmetics
Specific to cosmetics, per the National Law Review, thus far, individual states are starting to regulate PFAS intentionally added to cosmetics. California, Colorado, Maine, Maryland, Minnesota, Oregon, Vermont and Washington state are among these. Interestingly, Connecticut's Gov. Ned Lamont recently signed a unanimously passed bill for "forever chemicals," with a twist: a waiver should be included for keeping products on the market where there is no reasonable alternative, the CT Mirror reported.
On a national scale, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) requires the U.S. Food and Drug Administration (FDA) to assess the safety of PFAS in cosmetics and publish its results by the end of 2025. With several state bans effective as of Jan. 1, 2025, however, per the National Law Review, the intentional use of PFAS in cosmetics, regardless of possible toxicity issues or lack thereof, is coming to an end as manufacturers are being forced to reformulate. An additional ban on any PFAS above 100 ppm may also be on the horizon, the source notes.
"While it’s right to be concerned, rather than run straight into an outright ban for the entire class of chemicals, it’s time for a more surgical approach using science as the guide," Jeffreys writes.
Ubiquity and Classes of PFAS
"The U.S. Environmental Protection Agency (EPA) lists more than 15,000 PFAS chemicals in its CompTox database," Jeffreys continues. "These are chemicals used in everything from equipment vats that make shampoos or other household products, to non-stick cookware; from dental floss to waterproof outdoor gear. PFAS chemicals are also used in things like coatings for solar panels and screens for smartphones. The properties that make PFAS so effective in those thousands of products is also what makes them concerning – their inability to break down easily either in the environment or human body."
Jeffreys adds that the widespread use of PFAS materials and their persistence in the human body – which, they have been found in the blood of people and animals, as well as a variety of food products – have rightfully made them the target of much scrutiny in the regulatory and academic spaces. "They have also been found in water, air and soil at various locations throughout the globe," he notes.
The National Law review explains there are two main classes of PFAS: fluoropolymers (large molecules) and non-fluoropolymers (relatively small molecules). And while the generally non-toxic and inert fluoropolymers dominate industrial production, non-fluoropolymers, with a wide range of chemical reactivities, comprise the majority of PFAS in EPA’s database.
An article in Toxics adds that although some PFAS are known to be harmful, "a blanket ban may lead to significant problems in attempting to replace PFAS-based materials for environmental transition, as well as in medical devices and everyday products." Per the article, studies have shown that PFAS "exhibit a diverse range of mechanisms of action, biopersistence and bioaccumulation potential, and should thus not be treated as a single group.
"This is particularly true for the class of fluoropolymers," the authors state. These are the materials that have been used in cosmetics; polytetrafluoroethylene (PTFE) is perhaps the most common example.
PFAS in Cosmetics
Per the FDA, certain PFAS are intentionally added in some cosmetic products, including lipsticks, eyeshadows, moisturizers, rouges, nail polish and enamel, blushers and cleansers. They are used as emulsifiers, lubricants, rheology and texture moisturizers, shine enhancers, penetration and durability enhancers, hair conditioners, hair detanglers and more.
According to Debbie Waite, co-chief executive officer of Steinberg & Associates, originally, PTFE, a high-molecular weight synthetic fluoropolymer of tetrafluoroethylene, was the most commonly used PFAS cosmetic ingredient because it provided a smooth, sleek finish. However, most cosmetic companies have moved away from it.
Some PFAS may also be present unintentionally as the result of raw material impurities, or due to the breakdown of intentionally added PFAS ingredients that form other types of PFAS. Per Waite, for example, they may come from coatings on mineral or powdered raw materials.
Limited Data on PFAS Impact
"Much remains unknown about PFAS," Jeffreys writes. "Unlike some chemicals that have been known for hundreds of years, we are in the early days for PFAS chemicals. PFAS chemistry was first discovered in the late 1930s and started appearing in consumer products in the 1950s. But research into the impact of the entirety of PFAS chemicals has only been under way for the past few years, so data on the impact of each one of these 15,000+ ingredients is limited."
In fact, he explains that a recent analysis by machine learning* reviewing PFAS ingredients in the National Institutes of Health’s PubChem database showed "just 863 of them had any disease associated with them. That’s about 5%. In other words, about 95% of PFAS ingredients do not currently have any academic research linking them in any way – positive, neutral or negative – to a disease. That’s not to say in the near future this won’t change, but it is a snapshot of where we’re at now."
He continues, "Additional research is needed to understand exactly how harmful specific PFAS ingredients are in the various consumer products, as well as how to better detect PFAS, how much people are being exposed to the chemicals, and how to manage and dispose of PFAS. Until these questions are answered, there will be understandable concerns and even fears with regard to PFAS."
Indeed, the FDA has identified additional research is needed on:
- The toxicological profiles for PFAS in cosmetics;
- The extent to which various PFAS in cosmetics can be absorbed through the skin; and
- The potential for human health risks from exposure to PFAS in cosmetics.
See related: Europe's Wastewater Measure to Apply 'Polluter Pays' Fee for Microplastics, PFAS
Relation is Not Causation
"To be clear, even among the 863 PFAS ingredients with scientific studies about their impact, evidence just relating them to a disease does not mean there is a preponderance of scientific evidence to that effect," Jeffreys emphasizes. "For example, for the first time in October 2023, a study was released in the International Journal of Cancer exploring the ingredient perfluorooctane sulfonamidoacetic acid and its potential relationship to papillary thyroid cancer. But the authors concluded there is no clear link between the PFAS chemical causing thyroid cancer. It calls for more work to be done in that area."
On the other hand, he continues, "This does not suggest manufacturers, government agencies and consumer protection groups should ignore PFAS. Because the research is limited and new, there is a lot that remains unknown." Additional analysis* of the aforementioned 863 PFAS also showed that in Q4 of 2023 alone, 289 of these ingredients had at least one new possible disease associated with them. "This is worth exploring further," Jeffreys writes.
Follow the Science and PFAS Facts
"It's right to be concerned about PFAS ingredients. But as with any business or public policy decision, regulators, business leaders and public policy decision-makers should follow the science and facts," Jeffreys states. "A sweeping ban on PFAS chemicals may impact environmental efforts, such as alternative energy technologies in lithium batteries, PV panels, wind turbines and fuel cells, as well as have national security implications."
The article in Toxics agrees with this statement. "A targeted approach that considers the specific risks and benefits of each chemical may be more effective." The authors add that the proposed ban could have unintended consequences, since the use of some PFAS materials is associated with reducing greenhouse gas emissions and improving energy efficiency. "Policymakers must carefully weigh up the potential consequences before making a final decision on the ban," the authors conclude.
Jeffreys concludes, "Rather than pursue a total ban across the entire class of PFAS ingredients, a more thoughtful and deliberate approach would be to focus first on further evaluating those 863 PFAS ingredients where there is evidence of an association of some kind with a health or environmental concern, and monitor all 15,000+ PFAS ingredients for new scientific evidence of a link to diseases. Anything short of that approach would be disruptive without any basis in science or good public policy."
*Analysis was performed by the author's company, 4Sight
