REACH Revision 2025: A Critical Moment for European Chemical Safety
A Reflection on the REACH Revision 2025 Conference and the Path Forward
Susana Loureiro, University of Aveiro and SETAC Europe President
As President of SETAC Europe, I had the privilege of participating in the landmark conference “REACH Revision 2025: Simpler, Faster, Bolder,” held on 29 September in in Brussels, Belgium. This pivotal event – co-organized by Health and Environment Alliance (HEAL) and CHEM Trust – brought together a remarkable assembly of stakeholders to discuss the most significant revision of Europe’s flagship chemicals legislation in over a decade.
A Watershed Moment for Chemical Regulation
The conference took place at a critical juncture in European environmental policy. After years of delays and extensive stakeholder consultations, the European Commission is finally preparing to present its REACH revision proposal in the fourth quarter of 2025. The urgency was tangible throughout the day, underscored by Commissioner Jessika Roswall's opening remarks, where she emphasized the dual responsibility of protecting human health and the environment while ensuring European competitiveness in the chemical sector.
The event’s theme, making REACH “simpler, faster, and bolder,” resonated strongly with the diverse audience of policymakers, industry representatives, environmental NGOs, civil society representatives and scientists. This triad of objectives summarizes the ambitious yet necessary transformation that REACH must undergo to address the 21st-century challenges while learning from nearly two decades of implementation experience.
Key Scientific Insights and Debates
Biomonitorization and Chemicals of Concern: From Science to Policy
One of the most compelling presentations came from Marike Kolossa-Gehring, coordinator of the European Human Biomonitoring Initiative (HBM4EU) and Head of Toxicology at the German Environment Agency. Her keynote effectively set the scene for understanding pollutants of concern and priority substances, highlighting critical issues, such as phthalates and their often regrettable substitutions. Her warning about avoiding the repetition of past mistakes with bisphenol A and its alternatives was particularly striking, emphasizing the need for more comprehensive safety assessments before introducing substitute chemicals to the market. The Partnership for the Assessment of Risks from Chemicals (PARC) is following the path of HBM4EU, with a further development of tools to implement a next-generation chemical risk assessment to protect human health and the environment.
Of particular concern was her discussion of cadmium exceedance uptake from vegetarian diets, illustrating how environmental contamination can create unexpected exposure pathways that challenge traditional risk assessment approaches.
The Mixture Assessment Factor (MAF): A Scientific Imperative
The deep-dive session on MAF was one of the most technically rigorous discussions of the day. Led by Olwenn Martin, University College London, this session provided crucial scientific context for understanding why traditional single-substance risk assessments are insufficient in our modern chemical landscape.
The complexity of mixture toxicology was highlighted as well as the need for more sophisticated approaches to chemical risk assessment to better incorporate mixture considerations in regulatory frameworks.
The discussion revealed that while MAF values between 2 and 500 have been proposed in the scientific literature, a factor of 10 may be a good suggestion – consistent with traditional animal-to-human extrapolation factors used in toxicology – or a MAF of 5 for high-volume chemicals, as suggested by the CARACAL working group; however, the implementation details remain contentious among stakeholders.
Industry Perspectives and Implementation Challenges
The conference provided valuable insights into industry concerns about the REACH revision. Marco Mensink, European Chemical Industry Council (CEFIC), articulated the industry’s dual role – contributing to the problem while also being essential to finding solutions. His emphasis on the need for investment in alternative substances resonated with many participants, highlighting the economic realities of chemical innovation.
A particularly telling observation came from Patrick ten Brink, European Environmental Bureau, who noted the regulatory paradox: REACH requires rapid decisions (often less than a month) to approve chemicals for market entry, yet takes years to remove problematic substances once safety concerns emerge. This asymmetry in regulatory speed has contributed to the accumulation of potentially harmful substances in the environment and human tissues.
PFAS: A Case Study in Regulatory Evolution
The discussion of per- and polyfluoroalkyl substances (PFAS) provided a compelling case study in how chemical regulation must evolve. While acknowledging that certain medical devices require PFAS for their function, the consensus was clear that the widespread use of PFAS in applications like firefighting foams has created unacceptable environmental contamination in both aquatic and terrestrial ecosystems.
The German Federal Ministry'’s science-based approach, as presented by Oliver Eberhardt, demonstrated how national competencies can drive evidence-based chemical management, setting important precedents for EU-wide action.
The Path Forward: Balancing Protection and Innovation
The conference highlighted several critical areas where the REACH revision must deliver meaningful improvements. One of them is related to enhancing the digital infrastructure. The introduction of a “Digital Chemical Passport” emerged as a widely supported initiative that could significantly improve transparency throughout chemical supply chains. This innovation aligns with the broader digitalization objectives of the European Union while providing practical benefits for both industry and regulators.
As already mentioned above, a targeted mixture assessment is crucial, and rather than implementing a blanket MAF approach, the discussions suggested a more nuanced strategy focusing on chemicals that are close to reference safe exposure levels, particularly plant protection products, where the impact would be most significant. For REACH chemicals, the impact is expected to be less dramatic but still important for comprehensive protection.
Regarding streamlined procedures, the revision must address the fundamental inefficiencies in current REACH procedures, particularly in the evaluation and restriction processes. The goal of making decisions “faster” requires not just procedural changes but also enhanced technical capabilities at ECHA and in national competent authorities.
Challenges and Opportunities Ahead
The conference revealed both the complexity of modernizing REACH and the strong commitment across stakeholder groups to achieve meaningful improvement. While disagreements remain on specific technical issues, like MAF implementation and the scope of polymer registration, there is remarkable consensus on the need for a more efficient, science-based regulatory system.
However, recent developments have cast uncertainty over the revision timeline. In early October, the European Commission’s Regulatory Scrutiny Board (RSB) issued a negative opinion on the impact assessment for the REACH revision, following meetings between the relevant directorates-general. This development represents a significant setback for the Commission’s ambitious timeline to deliver the legislative proposal by year-end.
The RSB's negative opinion forces the Commission back to the drawing board, requiring a comprehensive revision of the impact assessment that accompanies the legislative proposal. This situation is particularly concerning given that the RSB had previously issued a positive opinion on REACH in 2022, but after further delays and a new Commission term, the impact assessment required renewal under changed political priorities.
The regulatory landscape has become increasingly complex, with the RSB having previously caused significant delays and weakened proposals for other major initiatives, including corporate sustainability legislation and environmental directives. If a second impact assessment also receives a negative opinion, the situation could become even more challenging for advancing meaningful chemical policy reform.
Parliamentary representatives have emphasized that while it is difficult to predict how the negative opinion will affect the timeline, maintaining ambition remains a key priority in advancing REACH reform. There is continued expectation that the Commission will deliver comprehensive chemicals legislation aligned with the broader Chemicals Strategy for Sustainability.
Perspectives on the delay vary significantly among stakeholders. Some environmental advocates view the postponement as potentially beneficial in the current political climate, where regulatory simplification pressures could risk weakening protection standards. Others argue that further delays undermine the urgent need to modernize chemical safety frameworks that have already been under revision for several years.
According to chemicals policy experts, the RSB’s negative opinion reflects concerns that the proposal lacks coherence with current political priorities as the objectives and focus have shifted considerably since the original 2022 impact assessment was prepared. The changing regulatory environment has created tensions between protecting public health and environmental standards while addressing industry competitiveness concerns.
The next few months will be crucial as the European Commission finalizes its response to the RSB’s concerns. The technical details of implementation will determine whether the revision achieves its ambitious goals of simplification, speed and boldness without compromising protection of human health and the environment. The scientific community’s continued engagement in providing robust evidence will be essential to navigate these regulatory challenges successfully.
SETAC Europe's Role in Science-Based Policy
As representatives of the scientific community, SETAC Europe members have a crucial role to play in ensuring that the REACH revision is grounded in the best available science. The interdisciplinary nature of our society – spanning environmental chemistry, toxicology, ecology and risk assessment – positions us uniquely to contribute to evidence-based policy development.
Our ongoing collaboration with regulatory agencies, industry partners and environmental organizations will be essential as the revision process moves forward. The SETAC community’s expertise in environmental fate and effects assessment, biomonitoring and ecological risk assessment provides a critical scientific underpinning for many of the proposed reforms.
The REACH revision represents a once-in-a-generation opportunity to update European chemical policy for the challenges of the 21st century. The conference demonstrated that success will require continued collaboration between scientists, policymakers, industry and civil society organizations.
As we move toward the Commission’s proposal later this year, the SETAC community must remain engaged in providing the scientific evidence and technical expertise needed to support sound policy decisions. Our commitment to Environmental Quality Through Science® has never been more relevant or necessary.
The stakes are high, but the potential benefits – for human health, environmental protection and sustainable innovation – make this one of the most important regulatory developments of our time. The path forward requires not just regulatory reform but a renewed commitment to the scientific excellence that has long been SETAC's hallmark.
Contact: [email protected]