Definitions create clarity when dealing with new technology, and are a prerequisite for legislation. Various organisations are working on standardising the terms "nanotechnology" and "nanomaterials".
Since nanomaterials are used in an extremely wide variety of specialised applications (medicine, chemicals, foodstuffs, etc.), definitions are often specific for the industrial sector of the application in question.
Several definitions are provided below for the two key terms "nanotechnology" and "nanomaterials".
Definition according to the International Organization for Standardization ISO:
“Nanotechnology” is the knowledge about how nanoscale materials can be manipulated and controlled in order to utilise their properties resulting from the special size- and structure-related properties of individual atoms and molecules, and which differ from larger-scale macroscopic materials.
Definition according to the Swiss Chemicals and Plant Protection Products Ordinance:
Nanomaterial: A material containing particles in an unbound state or as an aggregate or as an agglomerate, where one or more external dimensions is in the size range 1-100 nm, or a material where the specific surface area by volume is greater than 60 m2/cm3. A material is only considered to be a nanomaterial if it is deliberately produced to utilise the properties arising from the defined external dimensions of the particles it contains, or from the defined surface area by volume of the material. Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm are considered to be nanomaterials.
Applications for Authorisation or adaptation of medicinal products in Switzerland must state whether the medicinal product contains nano-particles.
The following definition is used in this context: Nanoparticle: at least one dimension in the size range 1-1,000 nm and a function or mode of action based on nanotechnological properties.
European Commission's framework definition:
On 18 October 2011, the EU Commission adopted the following recommendation for a framework definition of nanomaterials (summary):
‘Nanomaterial’ means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 to 100 nanometres (nm). In specific cases and where warranted by concerns for the environment, health, safety or competitiveness, the number size distribution threshold of 50% may be replaced by a threshold between 1% and 50%; fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials;
Where technically feasible and prescribed by specific legislation, nanomaterials may also be defined on the basis of their specific surface area by volume. A material should be considered as a nanomaterial when its specific surface area by volume is greater than 60 m2/cm3. However, a material which, based on its number size distribution, is a nanomaterial, should be considered as a nanomaterial even if it has a specific surface area lower than 60 m2/cm3.
European regulation on cosmetic products:
The European regulation on cosmetic products contains the following definition of nanomaterials:
"Nanomaterial" means an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.
European regulation on the provision of food information to consumers:
This regulation defines engineered nanomaterials as follows:
"Engineered nanomaterial" means any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale.
Properties that are characteristic of the nanoscale include:
(i) those related to the large specific surface area of the materials considered; and/or
(ii) specific physico-chemical properties that are different from those of the non-nano form of the same material.
- Complete framework definition in the Official Journal of the European Union dated 20 October 2011 (PDF, 703 kB, 09.11.2016)
- Scientific Basis for the Definition of the Term «Nanomaterial» (PDF, 500 kB, 09.11.2016)Background report by the Committee on Emerging and Newly Identified Health Risks SCENIHR on the EU definition
Last modification 20.03.2019