The European Commission’s Joint Research Centre
(JRC) has developed the world’s first certified nanoparticle reference
material based on industry-sourced nanoparticles. This new material will
help ensure the comparability of measurements worldwide, thereby
facilitating trade, ensuring compliance with legislation and enhancing
innovation.
Nanotechnology
offers a range of benefits over traditional materials and enables the
development of innovative applications and products. However, there are
often concerns about the safety aspects and to what extent these have
been investigated. High-quality measurements are the basis for reliable
safety assessments, process improvement, quality control and the
development of new nanotechnology applications.
Until
now, however, no certified benchmarks incorporating industrial
nanoparticles were available. Some synthetic materials were available,
but they were not fully representative for “real-life” measurements.
For
this reason, the JRC’s Institute for Reference Materials and
Measurements (IRMM) has produced the world’s first certified reference
material based on real-world, industry-sourced nanoparticles. The
material (ERM-FD100) consists of silica nanoparticles of a nominal
diameter of 20 nanometers (nm). Silica nanoparticles are amongst the
most widely used nanoparticles at the moment in products such as polish,
whiteners and dispersants.
This
material provides the basis for reliable hazard assessments and to
check that nanomaterials conform to the internationally accepted
definition, as laid down in the respective ISO (International
Organisation for Standardisation) technical specification. It will
enable producers of nanoparticles to monitor production quality over
time against a stable reference point, and to assess the impact of
process improvements. Furthermore, the certified reference material will
contribute to establishing market confidence, demonstrating that
nanomaterial products meet the customers’ technical specifications.
The
release of this certified reference material concludes several years of
product development, in which the homogeneity and stability of the
material were assessed. Particle size was measured in collaboration with
33 laboratories from 11 different countries in Europe, America and
Asia, thus bringing together expert knowledge from across the globe. The
material was assessed by different measurement techniques and allows
producers of nanoparticles (independent from their final use) to test
the size of their particles, including batch-to-batch variability and
determine whether or not the particles meet the intended production
specifications.
About comparability or measurements
Analytical
measurements form the basis for many decisions, not only in a legal
sense, but also in industry. Customers set technical specifications and
suppliers promise to meet these specifications. With increased
international trade, these measurements are usually performed by
different laboratories: the supplier tests samples before shipment and
the receiver tests them for acceptance. It is crucial that those two
measurements are comparable, i.e. that laboratories achieve the same
result for their analysis. Otherwise, unnecessary trade disputes emerge
or customers refuse to buy from unknown vendors and demand costly
testing procedures.
The
same applies in the legal arena. Companies must be sure that the
results of the official control laboratories are comparable to their own
results. Only then can they be sure that compliance with legal limits
shown by their own measurements also means compliance for the official
control laboratory. Therefore, comparability of measurements is a
prerequisite for the unequivocal administration of law for all decisions
based on measurements.
There
is, however, a third aspect of comparability of results: they must be
comparable not only between different laboratories, but also comparable
in time for one laboratory. Only if a laboratory is sure that the
measurement it carries out today is the same as two years ago, can it
make informed decisions. Process improvement relies on such comparisons.
Comparability of measurements is therefore a prerequisite for
innovation, process improvement and industrial quality control.
About reference materials
There
are countless examples in which accurate measurements are crucial, such
as hospital blood tests, measuring the size of nanoparticles or
checking shipments of foodstuffs for the presence of genetically
modified organisms, and they all have a direct impact on the citizens’
every day life.
Reference
materials play a crucial role behind the scenes, enabling analytical
laboratories over the world to carry out tests in a comparable and
harmonised manner. They are used by laboratories to calibrate their
instruments, to develop reliable testing methods and to perform their
regular quality controls.
The
JRC’s Institute for Reference Materials and Measurements (IRMM) is one
of the leading developers and producers of reference materials in the
world, particularly in the clinical, food and GMO application areas. It
currently provides over 760 reference materials, and distributes around
20,000 units per year.
The JRC’s Institute for Reference Materials and Measurements
The
mission of the IRMM is to promote a common and reliable European
measurement system in support of EU policies. Its prime objective is to
build confidence in the comparability of measurements by the production
and dissemination of internationally accepted quality assurance tools,
including reference materials, validated methods, reference
measurements, interlaboratory comparisons and training.
