Nanotechnology regulations aim to ensure that products containing nanoscale materials – including nanoparticles, nanoscale particles, nanomaterials, nanosized particles, nanosized materials, nano-objects and nanostructured materials – are manufactured and used in a manner that protects against unreasonable risks to human health and the environment.
Nanotechnology is a broad term used to describe the science of manipulating materials operating at a scale of 1 to 100 nm (1 billionth of a metre), i.e., nanomaterials. Nanomaterials may be used to exhibit characteristics such as increased strength, chemical reactivity or conductivity compared to the same material without nanoscale features.
Regarded as chemical substances under major global regulatory frameworks for chemicals, nanoscale materials are subject to the regulatory regime for the assessment and management of chemical substances. These include:
- Records keeping
- Safety data sheets
- Classification and labeling obligations
In the EU, nanomaterials are regulated by the REACH and CLP Regulations and a string of other regulatory instruments depending on the specific product, such as the Plastic Food Contact Material Regulation. Additionally, certain EU Member States, including France, Norway, Denmark and Belgium have adopted mandatory reporting of nanomaterial or products containing nanomaterials to their national products register or nano register.
In the United States, under TSCA, manufacturers of new nanomaterials are required to submit a pre-manufacture notice to the Environmental Protection Agency prior to manufacturing or importing of them. In Canada, manufacturers and importers of nanomaterials must ensure that they are in compliance with the Canadian Environmental Protection Act, 1999 and requirements related to Significant New Activities (SNAcs).
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