EU Introduces New REACH Regulation Restricting PFHxA to Protect Health and the Environment

On 19 September 2024, the European Commission (the “Commission”) announced significant amendments to the Registration, Evaluation, Authorisation and Restriction of Chemicals (“REACH”) Regulation, focusing on undecafluorohexanoic acid (“PFHxA”) and related substances. This decision marks a pivotal step in the EU’s efforts to protect human health and the environment from the risks posed by hazardous chemicals, especially per- and polyfluoroalkyl substances (“PFAS”). 

Scope of the New REACH Restrictions on PFHxA 

The new regulation is part of a broader initiative aimed at reducing PFAS emissions, addressing growing concerns about their persistence in the environment and minimising potential health risks. 

PFHxA, a member of the PFAS family, is known for its “forever chemical” properties, including extreme persistence, mobility in water, and bioaccumulation. PFHxA and related compounds resist degradation, accumulating in the environment and posing long-term contamination risks. Studies have linked PFAS exposure to serious health conditions, such as cancer, liver damage, and hormone disruption. The European Chemicals Agency (“ECHA”) has raised concerns over PFHxA, prompting the European Commission to introduce stricter controls on its use. 

The newly introduced REACH restrictions specifically target the use of PFHxA and related substances in sectors where the risks to human health and the environment are not adequately controlled. More specifically, the regulation bans PFHxA in consumer textiles, food packaging, impregnation sprays, cosmetics, and certain fire-fighting foams, which are significant sources of emissions due to their widespread use. 

However, not all industries will be subject to these restrictions. Certain sectors, such as semiconductor manufacturing, battery production, and green hydrogen fuel cells, are exempt due to the lack of viable alternatives. 

Phased Implementation: Transition Periods for Industries 

The new PFHxA restrictions will be implemented in phases, allowing industries time to transition to safer alternatives. The regulation will come into force 20 days after its publication in the Official Journal of the European Union. Depending on the application, businesses will have between 18 months and five years to comply. 

For example, PFHxA use in consumer textiles, food packaging, and some firefighting foams will be phased out over 18 months, whereas industries such as civil aviation will have up to five years to adapt. 

This staggered implementation allows industries time to develop alternative technologies while minimising supply chain disruptions. It also supports the Commission’s objective of fostering innovation in safer chemical substitutes and promoting sustainable industrial practices. 

PFHxA as a Substitute for PFOA: A Growing Concern 

PFHxA has often been used as a substitute for perfluorooctanoic acid (“PFOA”), another harmful PFAS compound previously banned in the EU. While marketed as a safer alternative, recent research suggests that PFHxA may pose similar risks due to its persistence and mobility in water. 

Although PFHxA is not currently registered for use in the EU, related substances are commonly found in consumer products such as textiles, firefighting foams, and food contact materials like paper and cardboard packaging. The Commission’s latest restrictions aim to reduce PFHxA emissions and prevent further contamination. 

Additionally, the Commission has stressed the importance of reducing PFAS emissions across all sectors, as these chemicals are increasingly detected in drinking water supplies and bioaccumulate in the food chain. 

A Balanced Approach to Regulation 

The Commission’s decision to restrict PFHxA under REACH is the result of extensive consultations with stakeholders, including EU Member States, industry, and environmental organisations, as well as scientific assessments by ECHA’s Risk Assessment Committee (“RAC”) and Socio-Economic Analysis Committee (“SEAC”). The committees concluded that limiting PFHxA use in high-risk areas, where safer alternatives exist, is the most effective approach without causing disproportionate socio-economic harm. 

The regulation strikes a balance between the environmental and health risks and the socio-economic impact of banning PFHxA in certain sectors and ensures that industry has the flexibility to comply without being exposed to undue economic pressure. 

The new restrictions also align with the EU’s broader goals under the Green Deal, which aims to achieve a toxic-free environment by 2050. Alongside PFHxA-specific restrictions, the Commission is reviewing additional proposals to regulate PFAS use in other sectors. 

Implications for Industries and Consumers 

For industries, the new restrictions underscore the urgency of identifying and adopting safer alternatives to PFHxA. Companies in the textiles, food packaging, cosmetics, and firefighting sectors will need to adapt their processes and supply chains to ensure compliance. Fortunately, safer alternatives are already available, particularly in the textile and packaging industries, where water-repellent technologies are rapidly evolving. 

Consumers, on the other hand, will benefit from reduced exposure to harmful chemicals in everyday products. The ban on PFHxA in consumer textiles and food packaging will significantly lower the risk of encountering these hazardous substances, leading to improved public health outcomes. 

Conclusion 

The Commission’s new restrictions on PFHxA under REACH are an important milestone in the fight against PFAS pollution (see also the EFS insight  about ECHA processes proposal to restrict PFAS). By targeting high-risk uses and encouraging the development of safer alternatives, the EU is taking proactive steps to protect human health and the environment. 

For industries affected by these regulations, the coming months will be crucial for innovation and adaptation. While the path to a PFAS-free future presents challenges, the long-term benefits of reduced chemical pollution and enhanced public health are well worth the effort. Product compliance, especially material compliance, plays a crucial role here, as companies must ensure that their materials meet the new requirements. This not only helps to minimise regulatory risks, but also enables companies to proactively develop sustainable and environmentally friendly alternatives.