The European Commission has adopted stringent measures under the REACH Regulation to restrict the use of undecafluorohexanoic acid (PFHxA) and its related substances, a subgroup of per- and polyfluoroalkyl substances (PFAS). It is distinct from the potential restriction on the entire PFAS group (‘universal PFAS restriction') which the European Chemicals Agency (ECHA) is assessing following a 2023 proposal by five European governments. These persistent chemicals are known for their environmental mobility and potential health risks, necessitating immediate regulatory action.
Understanding PFHxA and PFAS
PFHxA is part of the broader PFAS family, comprising thousands of synthetic chemicals designed for their resistance to heat, water, and oil. Commonly referred to as "forever chemicals," PFAS do not break down naturally, accumulating in the environment and human body over time. PFHxA and its precursors are specifically known for being highly mobile in water and persistent, meaning they can travel long distances from their source of release, contaminating soil, groundwater, and even drinking water supplies.
Why PFHxA is a Concern
PFHxA-related substances are used in a variety of consumer products due to their water- and stain-resistant properties. However, their ubiquitous presence in consumer articles like textiles, food packaging, and cosmetics means they are released into the environment throughout their lifecycle, from manufacturing to disposal. The environmental and health risks associated with PFHxA include potential links to adverse health effects such as liver toxicity, thyroid disruption, and developmental issues. Although PFHxA has been used as an alternative to the now-banned perfluorooctanoic acid (PFOA), its environmental persistence and widespread use present similar concerns.
Scope and Impact of the New Restriction
The new restriction under the REACH Regulation will target several key applications of PFHxA:
- Consumer Textiles: Items like rain jackets, which use PFHxA for water and stain resistance.
- Food Packaging: Includes products like pizza boxes, which are often treated with PFHxA for grease resistance.
- Waterproofing Sprays and Cosmetics: PFHxA is found in certain waterproofing sprays and skin care products.
- Firefighting Foams: Specifically in applications for training and testing.
This regulation does not affect PFHxA use in other critical applications, such as semiconductors, batteries, or fuel cells for green hydrogen, where no viable alternatives currently exist.
Background on EU's PFAS Strategy
PFAS have been increasingly regulated within the EU due to their persistent, bioaccumulative, and toxic nature. The REACH Regulation has been instrumental in identifying and restricting harmful chemicals. The EU has been proactively addressing PFAS contamination over the past two decades, aiming to minimize the environmental and health impacts of these substances. PFHxA's restriction is a continuation of this effort, following the EU's ban on PFOA, another widely used PFAS.
The Road to Implementation
The restriction on PFHxA will officially come into force 20 days after its publication in the Official Journal of the European Union. Depending on the product category, the industry will have a transitional period of 18 months to 5 years to comply with the new regulations. This timeline is designed to allow companies to transition to safer alternatives without significant economic disruption.
The Science Behind the Decision
The European Chemicals Agency (ECHA) conducted a thorough scientific assessment of PFHxA and its associated risks, leading to this decision. The assessment indicated that the use of PFHxA in specific products poses an unacceptable risk to human health and the environment. ECHA's Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC) played a crucial role in evaluating the potential impacts and the availability of safer alternatives, which guided the final restriction.
Official Statements
Margrethe Vestager, Executive Vice-President for a Europe Fit for the Digital Age, emphasized the importance of this restriction, stating,
The restriction on this sub-group of PFAS is one more milestone that brings us closer to a toxic-free environment. The restriction will ban the use of this ‘forever chemical’ in for instance consumer textiles, pizza boxes and some cosmetics. Our EU rules allow us to restrict harmful substances when there are safe alternatives. To the benefit of all consumers and for a green transformation of our society.
Maroš Šefčovič, Executive Vice-President for the European Green Deal, added,
We are removing harmful substances from products that citizens use every day, like textiles, cosmetics and food packaging. This restriction of PFAS is a decisive step in our strategy to boost sustainability, competitiveness and innovation in the chemicals sector. Substituting 'forever chemicals' helps to keep our environment healthy, preserve our resources, and drive innovation in cleaner alternatives. The direction is clear, and businesses will have sufficient transition periods to adapt.
PFHxA and its related substances have been monitored and studied extensively by environmental and health agencies due to their potential for long-term exposure and environmental accumulation. The new restriction is based on a comprehensive dossier that outlines the risks, exposure pathways, and socio-economic impacts of these chemicals, as submitted by Germany to the ECHA.
The European Commission's decision to restrict PFHxA and related substances marks a significant advancement in the EU's ongoing effort to combat PFAS pollution. This regulation reflects the EU's commitment to environmental protection and public health, emphasizing the need for sustainable alternatives in the transition toward a green and digital economy.
