Boosting advanced material's innovation - Are we regulatory prepared?

Area of Science:

• Materials Science
• Regulatory Science
• Chemical Safety

Background:

• European Commission policy emphasizes advanced materials (AdMa) for sustainability, competitiveness, and resilience.
• AdMa are deliberately designed materials with specific functionalities, supporting global challenges like energy transition and health.
• AdMa include nanomaterials and other novel materials expected to reach market quantities, posing chemical safety challenges.

Purpose of the Study:

• To identify and analyze regulatory challenges associated with advanced materials (AdMa), particularly those in the nanosize range.
• To explore legal definitions, classifications (substances, mixtures, articles), and methodological issues in AdMa risk assessment.
• To propose actionable steps for stakeholders to enhance regulatory preparedness and legal clarity for AdMa innovation.

Main Methods:

• Review of European Commission policy communications on AdMa.
• Analysis of regulatory challenges and legal questions concerning AdMa, including nanomaterials.
• Identification of research needs for fit-for-purpose regulatory risk assessment.

Main Results:

• AdMa present significant legal and chemical safety challenges, especially concerning their definition and classification.
• Current regulatory frameworks may not be fully equipped to handle the complexities of AdMa risk assessment.
• A need for enhanced regulatory preparedness and increased legal clarity for innovators is identified.

Conclusions:

• Addressing regulatory needs for AdMa is crucial for achieving the European Commission's strategic goals.
• A fit-for-purpose chemicals legislation and risk assessment framework are essential to facilitate AdMa innovation.
• Proactive engagement of policymakers, authorities, and innovators is necessary for regulatory preparedness.