Answering Your Frequently Asked Questions About PFAS - Part Two
Per- and polyfluoroalkyl substances (PFAS) are synthetic chemicals prized for their resilience to heat, water, and oil, making them prevalent in various industries worldwide, from firefighting foams to non-stick cookware. Yet, their durability and resistance to breakdown pose significant risks to both human health and the environment. Termed 'forever chemicals,' PFAS can accumulate in living organisms and drinking water, presenting persistent challenges.
Following on from our February Q+A, here are some more key PFAS questions that our experts have answered.
Are ALL PFAS bad?
This is NOT true.
In general, PFAS are persistent due to the presence of C-F bonds, which are one of the strongest bonds in organic chemistry. Therefore, PFAS can remain in the environment for several years without breaking down. Bioaccumulation of such substances over time may lead to toxic effects on humans and the environment, including cancer, reduced immunity and birth defects.
However, only a select few PFAS, such as PFOA and PFOS have been studied extensively, indicating toxicity to humans and the environment. Whether other PFAS lead to toxic effects is yet to be determined.
Certain PFAS are used for the betterment of humans and environmental health. For example, PFAS are used in pharmaceuticals for the treatment of diseases such as cancer (e.g. Fulvestrant, Sorafenib and Selinexor). Other key PFAS uses (categories and subcategories) were highlighted by Glüge et al. in 2020.
What are the key differences between the approach from the EU and the US (federal)?
The key differences between the approach of the European Union (EU) and the United States (US) at the federal level regarding PFAS regulation and management include:
Regulatory Framework
EU: The EU has established regulations governing PFAS under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. PFAS substances are subject to registration, evaluation, authorization, and restriction processes under REACH, which aims to ensure their safe use and minimize risks to human health and the environment.
Several PFAS appear on the REACH candidate list of substances of very high concern (SVHCs), and several additional PFAS are included in the community rolling action plan (CoRAP) for future evaluation of their potential risk to human health and the environment. Restrictions apply to certain PFAS groups such as perfluorinated carboxylic acids (C9-14 PFCAs), their salts and precursors. Looking ahead, the national authorities of Germany, Denmark, the Netherlands, Norway and Sweden have proposed a restriction that would apply to a wide variety of PFAS uses; this proposal would have wide implications for PFAS uses in the EU and is currently under evaluation.
In addition to REACH, multiple PFAS are also subject to classification, labelling and packaging (CLP) regulation, with a number already having a harmonised classification under the EU regulation.
US: In the US, PFAS regulation is primarily governed by various federal agencies, including the Environmental Protection Agency (EPA), which has issued health advisories and established guidelines for PFAS levels in drinking water. However, there is no comprehensive federal regulation specifically targeting PFAS substances.
Despite there not being a specific federal regulation for PFAS, specific provisions are made for PFAS under the Toxic Substance Control Act (TSCA). Specifically, additional reporting requirements are in force under Part 705, and the EPA recently finalised a significant new use rule (SNUR) that prevents anyone from resuming manufacturing or use of an inactive PFAS without EPA review. This SNUR effectively ensures that many of the PFAS currently inactive in the US economy may not re-enter use in the future.
Maximum Contaminant Levels (MCLs) in Drinking Water
EU: The EU’s recast of the Drinking Water Directive, which took effect on 12 January 2021, includes a limit of 0.5 µg/l for all PFAS. Here the EU has taken a grouping approach to restricting PFAS in drinking water, which is aligned with upcoming restrictions such as the restriction proposal to ban a wide range of uses of PFAS.
US: The EPA has issued a health advisory for two PFAS compounds, perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), recommending that combined concentrations of these chemicals in drinking water not exceed 70 parts per trillion (ppt). Some states have implemented their own, often stricter, regulations for PFAS in drinking water.
Phase-Out and Bans
EU: Under REACH, certain PFAS substances have been subject to restrictions or phase-outs based on their hazardous properties. For example, PFOS has been banned for most uses in the EU since 2008. The proposal for restriction on the manufacture, placing on the market and use of PFAS brought forward by many EU member-states does however propose restrictions for around 10,000 PFAS.
US: While the EPA has taken some actions to limit the use of specific PFAS compounds, such as PFOA and PFOS, there has been no comprehensive federal ban on PFAS substances. The recent SNUR applicable to inactive PFAS does however work to ensure inactive PFAS are effectively banned from the US economy.
You can visit the ECHA and EPA websites to learn more about the PFAS regulations.
What is essential use and how is this being implemented?
"Essential use" refers to the necessary and indispensable applications of certain substances, including PFAS, where no technically or economically feasible alternatives are available or suitable. This concept is often used in the context of regulatory measures to restrict or phase out the use of hazardous chemicals while ensuring that essential functions that rely on these chemicals can still be fulfilled.
In the European Union (EU), the concept of essential use is addressed within the framework of the REACH regulation. Under REACH, SVHCs, including PFAS, may be subject to authorization requirements if their use is deemed non-essential due to concerns regarding their hazardous properties. The authorization process involves evaluating the risks and benefits of continued use and granting authorization only if no suitable alternatives exist and the socio-economic benefits outweigh the risks.
Overall, the implementation of essential use provisions under REACH aims to balance the need for certain substances in essential applications with the protection of human health and the environment, promoting the transition to safer alternatives where feasible.
What are the key steps in the PFAS regulatory compliance journey?
As we see more and more regulatory action to restrict or ban the use of PFAS, it is imperative to understand and take the necessary steps to reach PFAS regulatory compliance.
At Yordas Group, we help clients through this journey. We understand that every client is different and processes within the journey have to be tailored accordingly. However, we see some key steps in this journey as shown in the figure below.
Stay tuned for our upcoming PFAS-related content where we will take a closer look at each of these steps.
With the constantly evolving nature of the PFAS regulatory landscape, such as the recent increase in regulatory obligations in the EU and the US, it is crucial to stay up-to-date with PFAS regulatory updates. At Yordas, our teams can offer assistance at every step to ensure your compliance with PFAS regulations. Get in touch with us today to find out how we can help you overcome your PFAS-related challenges.
Additionally, our team has developed a PFAS identification tool, which provides automated, case-by-case identification and screening for PFAS across your entire product portfolio, regardless of whether it appears on current lists or not. For more information on this tool, feel free to get in touch with our PFAS team.
You can also subscribe to our newsletter to stay on top of PFAS-related updates, changes and content.
About our experts
Jude Arokianathar, Product Stewardship Regulatory Consultant
Jude Arokianathar joined Yordas Group in 2021 as a Regulatory Consultant, following a Ph.D. in Organic Chemistry and MSci in Pharmaceutical Chemistry. He is part of the Product Stewardship team at Yordas Group, where he works closely with clients from various sectors such as automotive, aerospace and defense, and consumer to ensure their compliance with existing and upcoming chemical legislation. Jude specializes in PFAS-related legislation, and with his strong scientific and regulatory background, he provides clients with regulatory advice to assist them in preparing for upcoming PFAS bans/restrictions and participating in consultations. Additionally, he is responsible for preparing and delivering communications, including webinars, blogs and fact sheets, on PFAS and other substances of concern.
David Seed, Product Stewardship Regulatory Consultant
David Seed joined Yordas Group in 2023 as a Regulatory Consultant, with previous experience in business insight and a Master’s Degree in chemistry. Working as part of the Product Stewardship team, David works with clients from a wide variety of industries, helping to ensure their compliance with the regulatory landscape.
As part of his role at Yordas Group, David closely monitors worldwide PFAS regulations, providing clients with updates on relevant developments, providing specific advice on regulatory queries, and helping to develop Yordas’s capabilities and tools regarding PFAS compliance. His chemical knowledge and work regarding regulatory compliance ensure he is well-placed to advise on the nuances of PFAS and their regulation.