The Nanotechnology Industries Association's Director of Regulatory Affairs, Dr Blanca Suarez-Merino, has published a comprehensive analysis of evolving EU nanomaterial definitions and their impact on the cosmetics sector. The article appears in H&PC Today journal's October 2025 issue.
Dr Suarez-Merino examines how the European Commission's updated 2022 recommendation for defining nanomaterials could significantly affect cosmetics regulation if adopted by the Cosmetics Products Regulation. The analysis highlights critical differences between current cosmetics-specific definitions and the broader EU framework.
Key regulatory implications
The current EU Cosmetics Regulation defines nanomaterials as "insoluble or biopersistent and intentionally manufactured" materials with dimensions between 1-100 nm. However, the 2022 EU recommendation encompasses all naturally occurring, incidental, and manufactured nanomaterials, applying stricter classification criteria.
This shift could reclassify common cosmetic ingredients. Certain forms of titanium dioxide and silica currently regulated as nanomaterials might no longer qualify due to aggregation or surface coating effects. Conversely, materials like carbon black could newly face nanomaterial requirements if characterization reveals significant nanoscale particle populations.
Industry challenges ahead
The article identifies several technical challenges in characterizing nanomaterials under updated definitions, particularly regarding particle size measurement, distinguishing aggregates from agglomerates, and detection within cosmetic matrices. Advanced imaging techniques remain labor-intensive but necessary for accurate classification.
Dr Suarez-Merino emphasizes that harmonized definitions are essential for regulatory compliance, innovation support, and global trade facilitation. The analysis notes that several EU member states have already implemented national measures based on EC recommendations, creating a patchwork of requirements.
Timeline and transition considerations
The cosmetics regulation revision timeline extends through 2029, with evaluation results expected by mid-2026 and legislative proposals by late 2027. Industry stakeholders stress the need for clear transition mechanisms to manage positive lists of permitted nanomaterials and avoid market disruption.
The publication builds on Dr Suarez-Merino's presentation at the 9th ERPA Annual Summit on Regulations and Compliance for Cosmetics in Brussels in February 2025, demonstrating NIA's commitment to providing scientific expertise on regulatory developments affecting nanotechnology industries.
