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Substances and Products

Current status of substances and products regulations for nanotechnologies

SubstancesNanomaterials present regulatory challenges similar to those posed by products using other emerging technologies.  However, these challenges may be magnified both because nanotechnology can be used in, or to make, any product, and because, at this scale, properties of a material relevant to the safety and effectiveness of the  products might change repeatedly as size enters into or varies within the nanoscale range.  

In addition, the emerging and uncertain nature of the science and potential for rapid development of applications for products highlights the need for timely development of a transparent, consistent, and predictable regulatory pathway (FDA, 2007). However, due to the ongoing uncertainty regarding the environmental, health and safety implications of nanomaterials, there is significant debate concerning whether nanotechnology or nanotechnology-based products merit specific government regulation.

Several regulatory bodies have initiated activity to assess, and in some cases ensure, the coverage of nanomaterials under existing substances and products regulations.  Further information on the current stance of key regulatory bodies with regards to nanotechnology regulation, in Europe, United State, Canada, Australia and New Zealand, can be found below.

Europe

North America

Australia & New Zealand

Did you know?

4 µm is the median aerodynamic diameter of particles that fall within the respirable size range.