A technique-driven materials categorisation scheme to support regulatory identification of nanomaterials

Area of Science:

• Regulatory Science
• Materials Science
• Analytical Chemistry

Background:

• Global regulations for nanomaterials often trigger specific legal requirements based on particle size.
• Current methods for nanomaterial identification lack universal standardization, impacting legal certainty and international trade.

Purpose of the Study:

• To propose a robust categorization scheme for nanomaterials based on particle size measurement capabilities.
• To enhance the accuracy and acceptance of nanomaterial identification across regulatory bodies and industries.

Main Methods:

• Developed a categorization scheme driven by the performance of common particle size characterization techniques.
• Matched measurement technique capabilities with material property profiles for optimal size determination.
• Applied the scheme to the European Commission's nanomaterial definition metric.

Main Results:

• The proposed scheme facilitates the selection of appropriate size determination techniques for diverse materials.
• It enables accurate identification of nanomaterials, ensuring regulatory compliance.
• The scheme offers a pathway for acceptance by regulators, industry, and consumers.

Conclusions:

• Implementing this categorization scheme enhances regulatory assessment of nanomaterials.
• It promotes harmonized international standards for nanomaterial identification and trade.
• The scheme supports the safe development and global commerce of nanomaterials.