We are doing science for policy
The Joint Research Centre (JRC) is the European Commission's science and knowledge service which employs scientists to carry out research in order to provide independent scientific advice and support to EU policy.
JRC scientists contributed to an intra-laboratory study comparing the outcome of analytical results using ultracentrifugation for the identification of nanomaterials. This is important for the registration or authorisation process related to the nanoparticle content of various chemicals, cosmetic or food products.
Judging whether a material is a nanomaterial for regulatory purposes in Europe is based on measuring the relative number of particles above and below a 100 nm threshold.
JRC scientists – in close collaboration with researchers from the French CEA and Irish Trinity College – have demonstrated some shortcomings of currently used test methods when applied to the characterisation and safety assessments of medical-nanoparticles. There is a need to further assess the suitability of existing standardised methods used for safety and quality evaluations, especially for the next generation of nanomedicines.
Reliable and reproducible characterisation of nanomaterials has become a key challenge to understanding nanomaterial biocompatibility, risk assessment and possible toxicity mechanisms. JRC scientists contributed to the assessment of the reproducibility of two popular nanoparticle characterisation techniques, dynamic light scattering and differential centrifugal sedimentation.
JRC scientists have developed the first comprehensive inventory of publicly available tools that are ready to be used for nanomaterial safety assessment.
Experts from several German and French organisations - including scientists from EFSA and the JRC - reviewed the current application of classical and new nanomaterials in the context of regulatory requirements and standardisation for chemicals, food and consumer products. They concluded that nanomaterial characterisation is still challenging and the major bottleneck of risk assessment and regulation.
The JRC organised a dedicated workshop to bridge scientific communities involved in progressing the regulatory science of nanomedicines. There was a general agreement by the participants that existing standards and guidance documents might not be always sufficient for the regulation of nanomedicines due to their particularities.
JRC scientists, in collaboration with six Italian Institutions, demonstrated that vesicular nanocarriers such as niosomes, are able to entrap drugs for safe delivery to targets to treat acute and chronic inflammation.
The Joint Research Centre (JRC) of the European Commission (EC) has developed a new Certified Reference Material (CRM) for nanoparticle size analysis. The CRM (ERM-FD101b) is a suspension of silica nanoparticles of nominally 85 nm in diameter in an aqueous solution and has been developed to support the implementation of the EC nanomaterial definition.
JRC scientists investigated the influence of various purification processes onto the surface composition and chemistry of gold nanoparticles. This work is relevant for the successful application of gold nanoparticles especially to be used as biomedicals and biosensing devices.
A collaborative study, organised by JRC, investigated the comparability and reliability of particle size values measured by a commercial centrifugal liquid sedimentation technique. The study was carried out to support the implementation of legislation related to nanomaterials.
The outcome of the study shows that particle size results are comparable when the method is calibrated with a well-characterised, good quality calibrant and that results can be achieved with an accuracy of about 10 %.