Crucial Recommendations on the Regulatory Risk Assessment of Advanced Materials

On the 27. and 28. November 2023, the 1st MACRAMÉ Regulatory Risk Assessors Summit took place in Berlin, kindly hosted by the Project Partner BAuA (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (Federal Institute for Occupational Safety and Health).

Ahead of many research and innovation (R&I) projects, and fully aligned with the European Unions’ policies, the MACRAMÉ Project focusses its attention on five market-relevant Use-Cases of existing innovative products and processes containing Advanced Materials (AdMas).

Marking a pivotal event in highlighting challenges, needs, and gaps in the current regulatory frameworks related to risk assessment during the life cycle of AdMas and AdMas-containing products, the Summit provided a platform for expert insights, stakeholder perspectives, and interactive discussions, throughout three main sessions:

  • Session 1 – Expert Insights: This session established the foundational context for the summit discussions, concentrating on the current policy frameworks. Key highlights included the European Green Deal, lessons learned from EU-funded projects like Gov4Nano, and an in-depth look into the Safe and Sustainable by Design (SSbD) Framework and into concepts of Life Cycle Assessment (LCA). These presentations laid out a comprehensive picture of the evolving policy environment concerning AdMas.
  • Session 2 – Stakeholder Perspectives: Diverse viewpoints were showcased in this session, featuring short talks from regulators, representatives of large industries and Small and Medium-sized Enterprises (SMEs), researchers, and consumers. Each speaker shared their unique perspective on risk assessment in the AdMas and AdMas-containing product lifecycle context, spotlighting the various challenges faced by each group. This session concluded in a panel discussion that amalgamated insights from the previous expert talks with the various stakeholder viewpoints, enriching the depth of the discourse.
  • Session 3 – Interactive Breakout Sessions: The final session was marked by its interactive nature, with thorough discussions and analyses. Three breakout groups delved into specific challenges of risk assessment during the life cycle of AdMas-containing products. Each of these groups focused on either occupational, consumer, or environmental safety. The outcomes of these sessions included identified needs, issues, and future recommendations. These were later shared with all participants, fostering a collaborative approach.

Central themes of the Summit included the evolution of regulatory frameworks, the integration of SSbD with LCA, and the digital product passport (DPP). Needs were identified for unified terminology and testing methodologies for risk assessment. Emphasising collaborative innovation, the summit underscored the importance of transparent data management and adaptable LCA methodologies.

The Summit resulted in a diverse range of stakeholder recommendations that set the stage for further advancements in the MACRAMÉ Project. These discussions will help shape the direction for the upcoming 2nd MACRAMÉ Risk Assessors Summit (to be held in mid 2025). Outcomes and recommendations from the MACRAMÉ Project will be presented there and the crucial dialogue with essential stakeholders will continue.

The 1st MACRAMÉ Regulatory Risk Assessors Summit and the Harmonization & Standardisation Workshop (held online on 22nd-23rd November 2023), highlighted key challenges, needs, gaps, and recommendations in the risk assessment during the life cycle of AdMas-containing products. According to the ‘MACRAMÉ Engagement Roadmap’, these activities mark the transition from the first ‘Connect & Inform’-phase to the second ‘Collect & Integrate’-phase of the MACRAMÉ Project. This second phase will focus on assimilating the accumulated insights into the project’s ongoing activities by supporting its development of test guidelines and standards, as well addressing (part of) the challenges, gaps, and needs identified during the summit.

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Follow these links to find out more about the 1st MACRAMÉ Regulatory Risk Assessors Summit, or to download the Summit’s full summary report.

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