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European Commission Defines Nanomaterials

On October 18 2011 the European commission adopted the definition of nanomaterial as given in recommendation 2011/696/EU. This definition will allow EC to identify certain materials for which special requirements for example labeling or risk assessment may apply. One reason to establish the recommendation is to align the definition of nanomaterials to facilitate consistency in different areas of EU legislation and policy implementation.

What are nanomaterials?

Nanomaterials are 10.000 times smaller then the diameter of a human hair and are all around in everyday consumer products. Nanomaterials are functional or useful substances that contain a nanoparticle or materials with nano-scale structure that leads to a unique functionality. Due to their specific properties they help to improve product quality and make certain features possible. Increasing physical strength, chemical or microbiological properties or electrical conductivity are only a few examples where improved product performance would not be possible without nano-technology. Prominent examples are nanosilver in textiles or certain household appliances, carbon-nanotubes in batteries or reinforced plastics and nano-sized titanium or zinc oxides used in sunscreens and cosmetics.

According to their substance composition nanomaterials are the same as their macro counterpart chemicals. It is their reduced size and/or special made physical appearance that creates their unique features and change their properties compared to their macro-scale twins.

Risk of nanomaterials

Nanomaterials need special attention to understand eventual risks connected to them due to the fact that nanotechnology is a comparatively new branch of materials science, the rapid growth of technical applications and production as well as the fact that their physical and/or chemical properties have changed1. Hence risk assessment on environmental fate or human exposure established for conventional substances may not apply to them. In general nanomaterials are not per se dangerous but scientific uncertainty about the safety of nanomaterials exists in many aspects and therefore the safety assessment of the substances must be done on a case-by-case basis.

The European Chemical Agency (ECHA) has also recognized the necessity to deal with nanomaterials in the context of REACH and acknowledges that data gaps exist2.

Definition of nanomaterials

In order to allow a thorough review of nanomaterials there is certainly a need to define in the first place what may be understood as a material on nano-scale. Recommendation 2011/696/EU defines nanomaterials in summary as:

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.

One aim of the definition is to provide clear and unambiguous criteria to identify materials for which special considerations regarding risk assessments may apply. It is only the results of the risk assessment that will determine whether the nanomaterial has dangerous features and whether or not further action is necessary.

Impact on industry

A first reaction of the German Federation of the Chemical Industry (VCI)  claims that the new definition will make materials to nano (like pigments or fillers) which are in use for decades and have never been understood or featured as nanomaterials in the past3. According to VCI and following the definition in principle all colored everyday articles contain nanomaterials. Consequently the industry will need to revisit their material catalogues, determine if materials will fall under the definition and identify eventual new challenges like risk assessments or REACH registration for any material falling under the new definition of the European Commission.

1 European Union: Nanotechnology: potential benefits, unknown risks
Chemicals: REACH and nanomaterials
3 https://www.vci.de/Downloads/PDF/EU%20macht%20fast%20alle%20Alltagsprodukte%20zu%20„Nano“.pdf (German only)

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