REGULATION & COMPLIANCE
Additional challenges
The definition of the substance group is essential to determine which individual substances fall under the group regulation. In the case of PFAS, one challenge is that different regulatory bodies were using different definitions of the group.
For example the definition of PFAS used under TSCA is different to the one defined by the OECD( the latter requires at least one fully fluorinated carbon. In addition, the OECD updated its definition in 2021). 5 Therefore, it is essential to check which definition is used by the regulators and to be aware if fluorinated polymers are included. Chemical expertise is needed to confirm the belonging of a substance to a group, since regulation is no longer based on CAS numbers. In addition, it is important to understand the limitations on the completeness and correctness of substances belonging to a group.
EU focus on groups
PFAS are not the only group of substances that are undergoing regulation as a group. ECHA’ s assessment of regulatory needs( ARN) represents a screening for the need for regulatory actions and has been focusing heavily on groups of substances. 6 Grouping is done using an IT-based algorithm.
The outcome of this assessment could be a recommendation that no action is needed or to start an official regulatory process that can include restrictions, harmonised classifications or the identification as a SVHC. Several groups of substances that underwent the ARN process did show up on the updated restriction roadmap in 2025.7
References: 1: Stockholm Convention on Persistent Organic Pollutants( POPs), Overview of PFAS. https:// www. pops. int / Implementation / IndustrialPOPs / PFAS / Overview / tabid / 5221 / Default. aspx 2: European Commission, Persistent Organic Pollutants: Long-chain Perfluorocarboxylic Acids, Their Salts and Related Compounds. https:// ec. europa. eu / info / law / better-regulation / have-your-say / initiatives / 14834-Persistent-organicpollutants-long-chain-perfluorocarboxylicacids-their-salts-and-related-compounds _ en
3: European Chemicals Agency( ECHA), Questions and Answers on PFAS Opinions. https:// echa. europa. eu / documents / d / guest / echa _ qa _ pfas _ opinions _ final _ en 4: Government of Canada, State of Per- and Polyfluoroalkyl Substances( PFAS) Report and Proposed Risk Management Approach. https:// www. canada. ca 5: OECD, Reconciling Terminology of the Universe of Per- and Polyfluoroalkyl Substances: Recommendations and Practical Guidance, OECD Series on Risk Management, No. 61, OECD Publishing, Paris.
In addition, a recent CLP amendment to Regulation( EU) 2024 / 2865 made sure that a group of substance can also now undergo the harmonised classification and labelling process.
Steps to mitigate risk
The global regulatory landscape will continue to evolve, with both harmonisations and divergences, as authorities balance the needs of populations, economies, the environment and the future. For companies, developing and maintaining a robust compliance strategy will help to sustain business continuity. Selected key points from a robust compliance strategy include:
• Thorough knowledge of the supply chain & product portfolio
• Monitoring of regulations as they emerge & understanding regulatory impact
• Periodic reassessment of product-related compliance checks
6: European Chemicals Agency( ECHA), Assessment of Regulatory Needs. https:// www. echa. europa. eu / assessmentregulatory-needs 7: European Commission, CIRCABC Document on PFAS. https:// webgate. ec. europa. eu / circabc-ewpp / d / d / workspace / SpacesStore / 42cc336d-13ac- 4e26-bec0-406efd07577c / download 8: UL Solutions, Chemical Data and Compliance Management( ULTRUS). https:// www. ul. com / software / ultrus / chemical-data-compliance-management
• Technical expertise to know what mitigating actions are necessary to ensure compliance
• Comprehensive compliance solutions to bring consistency & efficiency
As the use of regulation by group increases, companies will need to adopt and adapt more detailed technical reviews, embedding databases such as the ChemAdvisor regulatory database into their IT systems and automated processes, to establish the link between a chemical substance present in a product and a group regulation affecting it.
The database comprises over 8,000 + regulatory lists, data on over 600,000 chemical substances from over 130 countries around the world, and extensive linking of group-based regulations to globally recognised identifiers, such as CAS RN numbers – enabling successful automated processing of complex compliance checks. UL’ s Ultrus * is one way to take control of your chemical data and compliance. 8 ●
*- ULTRUS is a registered trademark of UL
J j
Martina Schneider
REGULATORY AFFAIRS MANAGER
UL SOLUTIONS martina. schneider @ ul. com www. ul. com
42 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981