Approaches to regulating PFAS

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In the saga that is the regulation of PFAS substances, a number of differences between global frameworks and roadblocks are emerging.

While many countries agree that PFAS substances need considerable (further) restriction, there is little harmonisation of approach between them. These differences make it tough to understand what substances are within the scope and for industry to ensure it is compliant in each jurisdiction.

One reason for the confusion is there is little agreement about how PFAS substances should be defined. The EU uses the OECD definition consisting of 4730 substances, but both ECHA and the OECD limit the number of PFAS in scope to those that are or were used at one time. Therefore, there may be more substances included in future. 

On the other hand, the US EPA uses a different definition based on a two-carbon framework, which contains both CF2 and CF moieties on a saturated carbon. If the EPA uses their Master List of PFAS Substances, this almost triples the number of substances within scope, in comparison to the EU, to over 12,000. Different again is the definition used by some states, such as Maine, which has proposed a complete PFAS ban. 

Adding to the growing list of complications is that banning or restricting a full group of substances runs counter to the historical approach of EU REACH, which most often looks at substances individually on a hazard basis. Grouping allows regulators the flexibility needed to add substances later but makes it difficult for companies to know whether a list of substances is definitive. Adding substances later also gives rise to further confusion about what can be considered a PFAS, as it may leave the way open to the future inclusion of related compounds. Nevertheless, grouping is likely to be a recurring issue due to the Chemicals Strategy for Sustainability proposing a new grouping approach for the regulation of substances, indicating it is now the approach favoured by the Commission and ECHA.

The situation in the US was theoretically made easier with amendments to TSCA enacted under the Obama administration, eliminating the balance between risk and benefit of substances, and making it easier to enact bans and restrictions. For various reasons, the EPA also seems to be shifting from a risk-based condition of use approach to a hazard-based grouping approach. While both the EU and the US have historically mixed both hazard and risk approaches more than is commonly thought, it is significant that both are increasingly moving towards grouping.

Regardless of what happens at the US federal or EU-wide level, there will likely be further restrictions at the local level - at least in the US. For example, the first state-based PFAS regulations will take effect at the end of 2022 (in NY). Therefore, businesses looking to stay on top of regulatory changes will benefit from utilising a proactive chemical regulatory monitoring system.

In addition, the proposed US local regulations are sometimes more stringent than the federal ones, which may result in the EPA beginning to look to the states for leadership on chemical restrictions. Similarly, many countries are looking to see how others are regulating PFAS. We could, therefore, see countries copying other regulations with a first-to-the-post approach.

The PFAS group of chemicals represents an interesting case of public and political pressure moving ahead of science. Unfortunately, there is little toxicological data about the vast majority of PFAS chemicals and there is much debate about which exposure criteria should be used. For example, there are very few studies on inhalation, but this could be a critical factor in occupational exposure. Likewise, should the focus be on gathering data on PFAS and nursing mothers or on reduced vaccine efficacy in children?

However, all of this ignores a crucial part of the PFAS issue - i.e., the complexity of finding alternatives, which are often also restricted substances, or simply PFAS substances not included on the restricted lists. Since there are currently few viable alternatives to the use of these substances, we are likely to see some continued use. These uses are likely to be restricted to ‘critical use’ or ‘essential use’ criteria but have yet to be defined or worked out. For companies seeking safe alternatives, a safe and sustainable-by-design (SSbD) approach and sustainable chemicals management plan will be key. 

How can Yordas help?

Yordas continues to closely monitor all PFAS-related developments and offers a range of services to help you navigate all necessary steps needed to comply with changing regulations. For guidance with data reporting or if you have questions about PFAS, get in touch with us today by sending a message here.