As nanotechnology is still an emerging field, it can be difficult for companies to understand their requirements. We have identified some frequently asked questions (FAQs) with regards to regulation and standards to provide useful information relating to the health and safety of nanomaterials.
For any further queries, please get in contact.
What is a nanomaterial?
According to the EU definition, a nanomaterial is:
“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 nm - 100 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 %.
By derogation from the above, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials.”
Based on this definition, high-aspect-ratio nanomaterials (HARNs) are also included. HARNs are identified as:
Any elongated particle of a high-aspect ratio (with length/diameter ≥ 3) which has one or more external dimensions is in the size range 1 nm - 100 nm. Examples of HARN may include certain types of nanotubes, nanorods, and platelets, depending on their aspect ratio. Of particular concern are HARN that are biopersistant in the lungs and longer than 15-20 µm with diameters less than 3 µm, as these are considered to be potentially hazardous to human health (see information on the ‘fibre paradigm’ in an IOM review by Lang Tran).
What do I need to do to determine if my material is classed as a “nanomaterial”?
What do I need to do to ensure regulatory compliance?
Nanomaterials fall under the existing REACH and CLP definition of a substance, hence requirements outlined in both regulations apply.
SAFENANO can provide a range of bespoke services to help identify and address regulatory obligations for your nanomaterials and nano-enabled products. Take a look at our services page to find out more or contact us.
What approaches are needed to assess the hazard posed by nanomaterials?
The methods used to test nanomaterials very much depend on the context they are being tested in, for example for regulatory purposes or as part of research, in early stage development or at technology launch stages, but also the route of entry to the body and hazard endpoint of interest. Testing for regulatory purposes such as within chemical regulation (i.e. REACH regulation within the EU) or cosmetics regulation is very much prescribed and there are requirements to follow a of set guidelines such as those developed by the OECD.
How can it be determined if nanoparticles are released from a process in the workplace?
Several standards exist for exposure monitoring of nanomaterials in the workplace, including those prepared by ISO and BSI.
What standards are available with regards to the health and safety nanomaterials?
Standardisation activities in the nanotechnology field are taking place at the international level and in many countries, involving a broad range of interests and organisations. At the forefront of these activities are the following five bodies:
- International Organisation for Standardization (ISO)
- European Committee for Standardization (CEN)
- British Standards Institution (BSI)
- ASTM International
- OECD Working Party on Manufactured Nanomaterials (WPMN)