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Regulation

What is a nanomaterial?

Regulation

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”?

We provide a large variety of analysis to characterise their materials, go to our Material Characterisation page to find out more or contact us. ]

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 Regulatory Support 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.

To find out more about the services we offer that can help in hazard assessment of nanomaterials, visit our Hazard assessment and Toxicology page or contact us to discuss your specific requirements in more detail.

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.

SAFENANO provides expertise in exposure monitoring to identify and help you control exposure in the workplace. For further information, please visit our Workplace Exposure Monitoring page or contact us.

Did you know?

MWCNT-7 is classified by IARC as ‘possibly carcinogenic to humans’ (Group 2B).