PFAS restrictions in Europe: OringOne’s solution with NFS FKM compounds

The European regulatory context: PFAS restrictions and the REACH regulation

On January 13, 2023, the authorities of Denmark, Germany, the Netherlands, Norway, and Sweden submitted a REACH restriction proposal on PFAS to the European Chemicals Agency (ECHA). The initiative was published on February 7, 2023, with the aim of reducing PFAS pollution in the environment and improving the safety of products and processes for human health.

This is one of the most extensive restrictions ever proposed, covering thousands of chemical substances, including fluoropolymers and fluoroelastomers such as PTFE, FKM, FVMQ, and FFKM. However, the regulation does not differentiate between genuinely toxic substances and chemically inert ones, like fluoroelastomers, raising concerns within the industrial sector.

What are PFAS? definition and environmental implications

PFAS (Per and Polyfluoroalkyl Substances) are a large group of chemical compounds with varying properties and levels of toxicity.
One of the key technical characteristics of PFAS is their environmental stability: these compounds are extremely resistant to chemical degradation due to the strength of the carbon-fluorine bond, which gives them long-lasting persistence both in the environment and in biological tissues.

However, the current regulatory framework does not adequately distinguish between the different families of PFAS, treating together compounds with very different chemical properties and ecotoxicological behaviors. For example, fluoroelastomers and perfluoroelastomers exhibit low chemical reactivity and do not tend to bioaccumulate, making them inert under many environmental conditions.

A more precise regulatory approach, based on a detailed evaluation of the physicochemical properties and exposure mechanisms, could lead to more targeted and technically appropriate regulation.

EU Restriction and O-Rings: risks for the fluoroelastomer and perfluoroelastomer industry

FKM have been included in the restriction primarily due to their manufacturing process, which involves the use of harmful fluorinated surfactants. Although these chemical agents are not present in the final product, their use in production has raised regulatory concerns.

To optimize the manufacturing process of fluoroelastomer rubber compounds, Oringone has initiated the transition to NFS (Non-Fluoro-Surfactant) FKM compounds, eliminating the use of fluorinated surfactants. These substances, commonly used as processing aids in fluoropolymer production, improve filler dispersion and workability during mixing, but are characterized by high environmental persistence.

The new fluorosurfactant-free FKM compounds represent a technological advancement that allows for maintaining high performance in terms of mechanical properties, thermal stability, and processability, even in the absence of PFAS fluorosurfactants. This approach enables greater compliance with environmental regulations, improved traceability of raw materials, and stricter control over the chemicals used in the production of FKM seals.

In parallel, our production system is certified according to three key international standards:

• ISO 9001:2015, which ensures a quality management system based on traceable processes, strict control, and continuous improvement;
• ISO 14001:2015, which confirms our commitment to monitoring and reducing environmental impacts throughout the entire production chain;
• ISO 50001:2018, which certifies efficient energy management, aimed at optimizing consumption and reducing the company's energy footprint.

Thanks to these choices, we are actively committed to a more responsible and sustainable industrial future, in line with the increasingly stringent demands of the market and international authorities.

OringOne’s FKM NFS compounds: commitment to sustainability

◎ 85% of the FKM compounds used by OringOne are already based on NFS technology.
◎ Goal: 100% FKM NFS by 2026.
◎ Unchanged quality and resistance, guaranteed compliance.

At OringOne, we have made significant investments in research and development to ensure that our FKM NFS compounds meet the highest standards of quality and performance, with a particular focus on the sustainability of the materials.

Currently, the proposed regulation regarding PFAS in the European Union is under review, with the aim of establishing uniform restrictions at the community level. The draft includes the potential for granting temporary exemptions for specific industrial uses, contingent upon the submission of evidence related to research and development activities on PFAS-free alternatives.

During the transitional period, the involved companies may continue using PFAS within the permitted limits, alongside the evaluation of substitute solutions technically compatible with the application requirements, including those related to technical performance, reliability, and safety of the final products.

Thanks to these innovations, our FKM compounds remain an ideal solution for a wide range of industrial applications, from the most common to the most complex, ensuring compliance with current and future regulations.

OringOne’s commitment to sustainability and waste reduction

Despite the fact that FKM is at risk of restrictions due to regulatory concerns over PFAS, it is important to emphasize that there is no scientific evidence proving their danger.

The rubber industry is making significant strides to adapt to the new regulations, aiming to distinguish between materials that genuinely pose risks and those that are essential for the functioning of the industry.

OringOne is at the forefront of this transition, working to ensure safety and sustainability without compromising product performance.

In conclusion, the adoption of more stringent regulations by the ECHA and the European Union on PFAS represents a crucial step towards a more sustainable future. However, it is essential that these regulations are based on solid scientific evidence, recognizing the importance of materials such as FKM NFS fluoroelastomers, which offer high performance while meeting today’s needs.
With the joint commitment of the industry and authorities, we can hope to combine innovation, safety, and sustainability.

◎ Discover our FKM NFS compounds in our online shop: shop.oringone.com
◎ For more information, contact us: lab@oringone.com