In a new publication, RIVM indicates scientific challenges in the use of the EU (European Union) definition for nanomaterial in legislation. The European Commission recommends that a nanomaterial be defined as a material in which at least 50% of the number of the constituent particles is in the size range 1 - 100 nm. Regulation of nanomaterials, however, needs more than a definition alone.
In recent years, an increasing number of applications and
products containing or using nanomaterials have become available.
Knowledge on potential risks of these materials for humans and the
environment is currently insufficient. A clear definition to
discriminate nanomaterials from other materials is prerequisite to
include provisions for nanomaterials in legislation. In October
2011 the European Commission published the „Recommendation on the
definition of a nanomaterial‟, primarily intended to provide
unambiguous criteria to identify materials for which special
regulatory provisions might apply, but also to promote consistency
on the interpretation of the term „nanomaterial‟. RIVM describes
the current status of various regulatory frameworks of the European
Union with regard to nanomaterials, and major issues relevant for
regulation of nanomaterials are discussed. These include:
- What does the definition reveal about environmental, health
and safety risks of nanomaterials? The current definition is based
on a percentage of the particles that is smaller than 100 nm and is
not aimed at mapping out the risks of nanomaterials. The choice for
this size limit is pragmatic and lacks a solid scientific basis. To
enable a proper risk assessment, further insight is needed into the
relationship between the particle size of materials and their
effects on environmental and human health.
- Are current measurement techniques for chemicals suitable
for nanomaterials? There is a great variety of measurement
techniques and methods available, but at present it is not clear
what the most suitable technique for each case is.
- In which part of the life-cycle, from production to use,
will materials be examined to fulfil the criteria of the
definition? It will not be sufficient to determine only once in the
life-cycle whether a material is a nanomaterial, because the size
of particles (including nanoparticles) can change during the
life-cycle.
This will contribute to better understanding the implications of
the choices policy makers have to make in further regulation of
nanomaterials.
Publication
http://dx.doi.org/10.1016/j.yrtph.2012.11.007
See also
RIVM-report:
http://www.rivm.nl/Bibliotheek/Wetenschappelijk/Rapporten/2012/juni/Interpretation_and_implications_of_the_European_Commission_s_definition_on_nanomaterials