Challenges of Regulation and Risk Assessment of Nanomaterials

Although the ISO framework for LCA is not specific for nanomaterials, it can be adapted to them. The
main problem with LCA of nanomaterials and nanoproducts is the lack of data and understanding in
certain areas. Major efforts are needed to fully assess potential risks and environmental impacts of
nanoproducts and materials (not just those related to LCA). There is a need for protocols and
practical methodologies for toxicology studies, fate and transport studies and scaling approaches.
Further research is needed to gather missing relevant data and to develop user-friendly eco-design
screening tools.
Nanopolytox will address the following issues for nanomaterials over their life cycle: physical and
chemical characterization at the different stages; hazard characterization (human toxicity and
ecotoxicity) at the different stages; transformation, migration and release of nanomaterials included
in products; environmental and biological fate of released nanomaterials; LCA analysis of
nanomaterials included in polymeric products; technological solutions for recycling and final
treatment of polymer nanocomposites. S. Vázquez Campos, summarised the Nanopolytox workplan
and timelines as well as its methodological aspects. The project will finalise in 2013.
The presentation on Health, Safety, and Environment: Assessment Methods was made by D.
Hristozov, including the comprehensive weight of evidence approach adopted within the ENPRA
project. According to him, substantial limitations and uncertainties hinder the risk assessment (RA)
and the lifecycle assessment (LCA) of engineered nanomaterials (ENMs), thus making difficult the
implementation of appropriate risk management measures.
Limitations of conventional RA lie mainly in the fields of hazard identification, dose-response
relationship assessment and exposure assessment. Accordingly, there is an Increasing interest in
development of complementary methodologies methodologies/models (as the XL
Insurance Database Methodology, the precautionary matrix for synthetic nanomaterials, the ANSES
System, the Stoffenmanager Nano 1.0 and the NANOSAFER) and tools (weight of evidence (WoE),
multi criteria decision analysis (MCDA), control banding, expert elicitation (EE)) for RA of ENMs. After
making a review of them, the presenter concluded that none of the methodologies/models are
intended to facilitate regulatory decision making, but instead mostly to serve as preliminary risk
screening tools for use by SMEs and industry. There is indeed a need for quantitative risk assessment
approach supporting near-term regulatory decisions.
On the other side, although LCA is usually applied to matured technologies, there is a general trend
toward an earlier adoption of LCA, indeed LCA of nanotechnology and nanoproducts can provide an
opportunity for precautionary action in order to prevent or minimize potential impact to human
health and the environment and can add supplementary environmental information to support
decisions on the regulation of certain nanomaterials or nanoproducts. However few LCA studies on
nanotechnologies have been published and whereas the ISO 14040 framework is appropriate, a
number of issues need to be addressed as the lack of inventory data: (i.e. data about nanomaterial
releases during manufacturing, use and disposal stages are not available) and how to correlate the
nanomaterials releases with the characterization factors/ environmental indicators used within the
LCA framework.
Actually RA and LCA procedures are complementary. Indeed, although LCA is readily applicable to
nanoproducts, the methodology faces limitations when addressing the toxicity of ENMs released
throughout their life cycle, which is a strength of the RA. Both LCA and risk assessment are costly
exercises, integration of RA and LCA (i.e. a pragmatic screening approach combining the use of LCA,
risk assessment and scenario analysis) holds promise to support a more holistic nanotechnological
assessment that will allow better understanding of the environmental and health impacts and the
economic and social benefits of the nanoproducts. Clearly understood and communicated benefits
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