This portal is developed by the EU H2020 projects RiskGONE, NANORIGO and Gov4Nano
and aims to become a one-stop-shop to access nanospecific information,
guidance, methods, tools, and data to support risk governance of nanotechnologies.
Nanomaterial according to the COMMISSION RECOMMENDATION of 10.6.2022
1. 'Nanomaterial' means a natural, incidental or manufactured material consisting of solid particles that are present, either on their own or as identifiable constituent particles in aggregates or agglomerates, and where 50 % or more of these particles in the number-based size distribution fulfil at least one of the following conditions:
(a) one or more external dimensions of the particle are in the size range 1 nm to 100 nm;
(b) the particle has an elongated shape, such as a rod, fibre or tube, where two external dimensions are smaller than 1 nm and the other dimension is larger than 100 nm;
(c) the particle has a plate-like shape, where one external dimension is smaller than 1 nm and the other dimensions are larger than 100 nm.
In the determination of the particle number-based size distribution, particles with at least two orthogonal external dimensions larger than 100 µm need not be considered.
However, a material with a specific surface area by volume of < 6 m² /cm³ shall not be considered a nanomaterial.
2. For the purposes of point 1, the following definitions apply:
(a) particle means a minute piece of matter with defined physical boundaries; single molecules are not considered ‘particles’;
(b) aggregate means a particle comprising of strongly bound or fused particles;
(c) agglomerate means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components.
Nano-object. Discrete piece of material with one, two or three external dimensions in the nanoscale (ISO/TS 80004-1:2015, 2.5)
Manufactured nanomaterial. Nanomaterials intentionally produced to have selected properties or composition (ISO/TS 80004-1:2015, 2.9)
Engineered nanomaterial. Nanomaterial designed for specific purpose or function. (ISO/TS 80004 1:2015, 2.8)
Nano-enabled. Exhibiting function or performance only possible with nanotechnology (ISO/TS 80004 1:2015, 2.15)
Risk ISO 73 and ISO 31000 (2019) define risk as the "effect of uncertainty on objectives". Risk is usually expressed in terms of risk sources, potential events, their consequences and their likelihood.
Risk assessment. The overall process of risk identification, risk analysis and risk evaluation. Risk assessment should be conducted systematically, iteratively and collaboratively, drawing on the knowledge and views of stakeholders. It should use the best available information, supplemented by further enquiry as necessary (ISO 31000:2018, 6.4.1)
Risk identification. The purpose of risk identification is to find, recognize and describe risks that might help or prevent an organization achieving its objectives. Relevant, appropriate and up-to-date information is important in identifying risks. (ISO 31000:2018, 6.4.2)
Risk analysis. The purpose of risk analysis is to comprehend the nature of risk and its characteristics including, where appropriate, the level of risk. Risk analysis involves a detailed consideration of uncertainties, risk sources, consequences, likelihood, events, scenarios, controls and their effectiveness. (ISO 31000:2018, 6.4.3)
Risk evaluation. The purpose of risk evaluation is to support decisions. Risk evaluation involves comparing the results of the risk analysis with the established risk criteria to determine where additional action is required. (ISO 31000:2018, 6.4.3)