Review of Recent Reports and National Research Council Committee Workshop - Research Progress on Environmental Health and Safety Aspects of Engineered Nanomaterials - page 15

methods for characterization, exposure assessment, hazard identification, life-cycle assessment, and
simulation, including research on fundamental interactions of ENMs with living organisms; developing
suitable reference ENMs for methods development, validation, and quality assurance; developing public
databases to serve in the safety assessment of ENMs; and increasing the development of test guidelines
and standards within OECD, ISO, and the Comité Européen de Normalisation.
The EC also has published two regulatory reviews on nanosciences and nanotechnologies—the
first in 2008 (EC 2008) and the second in 2012 (EC 2012). On the basis of a number of pan-European
reviews and analyses of the state of the science and its relevance to regulation, the review concluded that
(EC 2012, p. 11)
In the light of current knowledge and opinions of the EU Scientific and Advisory Committees and
independent risk assessors, nanomaterials are similar to normal chemicals/substances in that some
may be toxic and some may not. Possible risks are related to specific nanomaterials and specific
uses. Therefore, nanomaterials require a risk assessment, which should be performed on a case-
by-case basis, using pertinent information. Current risk assessment methods are applicable, even
if work on particular aspects of risk assessment is still required.
The definition of nanomaterials will be integrated in EU legislation, where appropriate. The
Commission is currently working on detection, measurement and monitoring methods for
nanomaterials and their validation to ensure the proper implementation of the definition.
Important challenges relate primarily to establishing validated methods and instrumentation for
detection, characterization, and analysis, completing information on hazards of nanomaterials and
developing methods to assess exposure to nanomaterials.
In 2004, an EC project was funded to coordinate activities between researchers working on the
responsible development of ENMs. NanoImpactNet (NanoImpactNet 2013) ran from 2004 to 2012 and
was highly influential in achieving coordination among research groups working on FP6 and FP7 projects
across Europe. The key aims of NanoImpactNet were to facilitate collaborations among research projects,
communicate results to stakeholders and communicate their needs back to researchers, and help to
implement the EC's action plan for nanotechnology. Following in part from NanoImpactNet, all EC
research projects addressing the potential risks associated with ENMs are coordinated through the EC
NanoSafety Cluster (NanoSafety Cluster 2013), an EC initiative aimed at ensuring strong strategic
synergy in the field of EHS nanotechnology research.
The EC NanoSafety Cluster is designed “to maximise the synergies between the existing FP6 and
FP7 projects addressing all aspects of nanosafety including toxicology, ecotoxicology, exposure
assessment, mechanisms of interaction, risk assessment and standardisation” (NanoSafety Cluster 2013).
The objectives “are to facilitate the formation of a consensus on nanotoxicology in Europe; to provide a
single voice for discussions with external bodies; to avoid duplicating work and improve efficiency; to
improve the coherence of nanotoxicology studies and harmonize methods; to provide a forum for
discussion, problem-solving, and planning of R&D activities in Europe; and to provide industrial
stakeholders and the general public with appropriate knowledge on the risks to human health and the
environment posed by ENMs” (Nanosafety Cluster 2013). Current or completed projects in the cluster
represent an R&D investment of about €137 million (about $180 million).
In association with the NanoSafety Cluster, a US-EU discussion on ENM safety research
(Finnish Institute of Occupational Health 2012) was formalized in 2011, and there continue to be regular
meetings of researchers from both sides of the Atlantic. Through that mechanism, communities of
research (CoRs) are being established between the US and the EU. The CoRs are addressing exposure
through the life cycle, ecotoxicity testing and predictive models, predictive modeling for human health,
databases and ontology, risk assessment, and risk management measures.