Global Regulatory Requirements: Overview of Nanomaterial Safety Testing

K.J. Ong, J.A. Shatkin, J.D. Ede
Vireo Advisors,

Keywords: nanomaterial, regulation, definition, TSCA, REACH, toxicity testing, safety


The regulatory requirements for registration and authorization of nanomaterials are continually changing, and focus on ‘nanoforms’ is ever increasing. Defining ‘nano’ has been a challenge for regulatory agencies around the world, impacting manufacturer, supplier, and importer obligations and creating uncertainty. Some regulatory agencies are requiring nano-specific information to allow for assessment of safety, such as physicochemical property data and safety data to demonstrate that nanoforms have the same biological effects as their conventional counterparts. This presentation will give an overview of the updates on global regulatory requirements for safety information as it pertains to nanomaterials and some common application areas, including industrial chemicals, food and feed, food contact materials, paper and packaging, and cosmetics. There will be a comparison of recent regulatory changes that directly affect nanomaterial commercialization and safety testing, such as the US TSCA Nano Reporting Rule and various National Nanomaterial Registries, updates on regulatory definitions of ‘nano’, and the EU’s nanoform amendments to REACH, as well as an overview of some major changes in other geographical markets. In addition, we will highlight new research, guidance, and recommendations regarding safety testing of nanomaterials that help companies develop a safety testing plan to meet regulatory standards.