European Union

A “nanomaterial” is still generally undefined. There is some debate between the EU and international standard authorities as to defining the size range, distribution, constituency, agglomeration, measurements and origins of the nanomaterial. The pending definition is a natural or manufactured material in the size range of 1 to 100 nm with a median 50% constituency assuming a normal or log-normal distribution. However, aggregation and agglomeration are not quantified, nor the specific measurement method defined that could be considered universal for all nanomaterials. The definition is based upon the preliminary work of the International Organisation for Standardization (ISO) (see above), the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and the Joint Research Centre (JRC).

REACH (Registration, Evaluation, Authorisation and Restriction of Chemical substances) seems to be more so affected because of additional factors including nanoscale form, solubility, surface charge, reactivity etc. that can greatly affect our health and environment.

Ongoing efforts are made by the EU to better overcome such nano-health uncertainties. The German Social Accident Insurance (DGUV) has recently launched the Nano-Platform “Safe handling of Nanomaterials”.  The interactive platform teaches which nanomaterials and nano-products are used in one’s respective trade. NanoDiode (innovative Outreach and Dialogue on responsible Nanotechnologies in EU Civil Society) is another and direct approach to establishing dependable collaborations with the public on health related issues of nano.

||Public concerns

NGOs, such as Health Care Without Harm, are urging the EU to accelerate health effect studies of nanomaterials. They argue that:

  • REACH should extend any definition of nanomaterial beyond the size threshold of 100 nm
  • EU law does not take into account that different forms of a substance are different and have different properties from their bulk counterpart;
  • Six years after REACH registration requirements, only nine substances have been registered as nanomaterials. REACH’s fundamental principle of “no data, no market” should be thoroughly implemented;
  • Up-to-date knowledge must be kept by ECHA to systematically check compliance for all nanoforms, as well as check the compliance of all dossiers; and
  • Provide public communication and decision making ability on market products.
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