TDMA clarifies nanomaterial confusion in new titanium dioxide guidance

In the European Union (EU), there are multiple legal definitions of a nanomaterial [1], with even more variations worldwide that are not aligned. In both scientific publications and regulations, there is considerable confusion surrounding this topic.

This is particularly important for titanium dioxide (TiO₂), more than 98% of the material placed on the market is in non-nano pigmentary form, valued for its ability to scatter visible light and deliver whiteness, brightness, and opacity. In contrast, less than 2% of TiO₂ is used in nanoform, typically for specialised applications such as industrial catalysts. Yet despite this distinction, inconsistent terminology and assumptions about hazard have led to confusion in both publications and policy.

Multiple EU scientific bodies have reiterated that the various nanomaterial definitions are based on size only and do not necessarily imply any hazard. The EU Guidance on the implementation of the Commission Recommendation 2022/C 229/01 on the definition of nanomaterial produced by the EU Joint Research Centre (JRC) states that “nanomaterials can be hazardous, or not, and a definition based only on size properties cannot differentiate between hazardous and non-hazardous materials” [2].

The objective of this document is thus to provide clarity and guidance in this area for scientific and regulatory purposes and includes a glossary and explanation of the many different terms used in this field. The TDMA has endeavoured to align this information as closely as possible with EU regulations and documents.

The TDMA hopes that the information sheet will improve understanding in this area, assist in the selection of appropriate forms for studies or even avoid unnecessary studies being undertaken. TDMA welcomes feedback and will continue to update the document to reflect evolving regulatory landscapes.

Click here to access the information sheet

[1] European Commission. Commission Recommendation of 10 June 2022 on the definition of nanomaterial (2022C 229/01). s.l. : Official Journal of the European Union, 2022.

[2] Rauscher, H., Kestens, V., Rasmussen, K., Linsinger, T. and Stefaniak, E.,. Guidance on the implementation of the Commission Recommendation 2022/C 229/01 on the definition of nanomaterial, EUR 31452 EN. Luxembourg : Publications Office of the European Union, 2023.