Examples of existing definitions
Summary
The document outlines nanomaterial definitions from the ISO, OECD, EU, and various US and Canadian agencies, noting that most center on a size range of 1nm to 100nm. It highlights that the European Union uses a specific particle number distribution threshold (50% or more) and a surface area by volume ratio proxy. The briefing concludes that divergent definitions lead to legal uncertainty, where a substance may be regulated as a nanomaterial in one jurisdiction or product category but treated as a bulk substance in another.
Key insights
- The International Organization for Standardization (ISO) provides a foundational definition of nanomaterial as having external dimensions, internal structure, or surface structure in the nanoscale, which it defines as ranging from approximately 1nm to 100 nm.
- The OECD defines a nanomaterial as a chemical that is either a nano-object (confined in one, two, or three dimensions at the nanoscale) or nano-structured (having internal or surface structure at the nano scale), with the nano-scale typically between 1nm and 100 nm.
- The United States lacks a single regulatory definition; instead, the EPA uses a working definition from the National Nanotechnology Initiative, and the FDA identifies nanomaterials as those with at least one dimension between approximately 1nm and 100nm or those exhibiting related dimension-dependent properties.
- Health Canada's working definition includes materials with at least one external dimension, or internal/surface structure, within the 1 to 100 nanometer range, as well as materials outside this range that exhibit nanoscale properties or phenomena.
- The European Commission's 2011 recommendation defines nanomaterials based on a number size distribution where 50% or more of particles have one or more external dimensions between 1nm and 100nm, though it allows for lower thresholds based on safety or competitiveness concerns.
- The European Union's definition specifically includes fullerenes, graphene flakes, and single wall carbon nanotubes with dimensions below 1 nm, and allows a specific surface area by volume ratio of 60m2/cm3 to be used as a proxy to establish a material as a nanomaterial.
- Inconsistent definitions across jurisdictions create legal uncertainty and regulatory gaps, potentially resulting in a substance being regulated as a nanomaterial in the EU but as a bulk material in the US, or being treated differently depending on whether it is used in biocides versus cosmetics.
Cite the original document
- APA
- Center for International Environmental Law (n.d.). Examples of existing definitions. https://www.ciel.org/wp-content/uploads/2015/07/Nano_definition_Nov2014.pdf
- Chicago
- Center for International Environmental Law. Examples of existing definitions. n.d. https://www.ciel.org/wp-content/uploads/2015/07/Nano_definition_Nov2014.pdf.
- Wikipedia
- {{cite report |author=Center for International Environmental Law |title=Examples of existing definitions |url=https://www.ciel.org/wp-content/uploads/2015/07/Nano_definition_Nov2014.pdf |access-date=17 August 2026 |via=Climate Insights Directory}}
- BibTeX
- @techreport{centerforinternationalenvironmentallawndexamples, author = {{Center for International Environmental Law}}, title = {{Examples of existing definitions}}, institution = {Center for International Environmental Law}, url = {https://www.ciel.org/wp-content/uploads/2015/07/Nano_definition_Nov2014.pdf}, urldate = {2026-08-17}, note = {Indexed by Climate Insights Directory} }
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