WP6

Regulatory Preparedness

Objectives

To explore how safety regulations can keep pace with the innovations in MCNMs, thereby elaborating on current developments in regulations to accommodate the unique characteristics of MCNMs. To facilitate that the scientific knowledge, tools and data generated in SUNSHINE are taken up by regulators and standardisation bodies for the adaptation of current regulatory guidance and standard guidelines for MCNMs. To ensure that the safety aspects of MCNMs are addressed as part of the activities of the Nanotechnology Risk Governance Council. Steps will be taken to move towards S&SbD by developing this concept further for MCNMs because it is necessary to support efforts of the EC in their continuation for reaching Green Deals goals, despite the present economic situation.

Methodology

The current regulatory guidance documents (e.g. REACH, Biocides, Consumer Products, Food and Feed, Medicine) are used as a starting point to assess if they can adequately address the possible environmental and health risks of MCNMs. Recommendations will be made on adapting the respective regulatory guidance documents for MCNMs based on the results of the project. Since international standardisation is key to regulatory acceptance of data, the suitability of OECD, ISO and CEN guidelines for safety assessment of chemicals and NMs will be assessed, and recommendations will be made on their adaptation for MCNMs. The S&SbD concept will be further developed with industrial showcases.

Key Outcomes

Recommendations for improvement and adaptation of the existing regulatory guidance and standard guidelines for MCNMs. Two-way dialogue between industry and regulators to anticipate any EHS issues with the MCNMs early in the innovation process in order to save RTD costs and bring the products faster to the market. S&SbD concept development for MCNMs for reaching Green Deal goals.

Work Package Leader

RIVM