Nano or Not Nano? A Structured Approach for Identifying Nanomaterials According to the European Commission's...

Area of Science:

• Materials Science
• Nanotechnology
• Regulatory Science

Background:

• Identifying nanomaterials (NMs) under European Union legislation is complex due to diverse material properties.
• Existing methods require careful selection based on material characteristics and measurement technique performance.

Purpose of the Study:

• To present the NanoDefiner Framework and its Decision Support Flow Scheme (DSFS) for classifying nanomaterials.
• To offer a reliable, economic, and scientifically-grounded approach for NM identification.

Main Methods:

• The DSFS utilizes a proxy approach, first identifying non-NMs via volume-specific surface area.
• It then proceeds to identify NMs based on scientific criteria and regulatory requirements.
• The framework is implemented in an e-tool and tested on real-world materials.

Main Results:

• The DSFS provides a structured decision-making process for NM identification.
• It was compared to the European Commission's Joint Research Centre (JRC) flowchart, demonstrating complementary approaches.
• The NanoDefiner Framework prioritizes non-NM identification, while the JRC flowchart focuses on NM identification.

Conclusions:

• The NanoDefiner Framework offers an effective and efficient strategy for nanomaterial identification.
• It aligns scientific assessment with regulatory needs, facilitating compliance.
• The DSFS provides a valuable tool for researchers and regulators in the field of nanotechnology.