This report as part of the Series on the Safety of Manufactured Nanomaterials reviews the terminology represented by Safe( r) by design and regulatory preparedness. This approach is presented as a way to minimise the gap (a) for industry to try to reduce uncertainties and risks to human and environmental safety, starting at an early phase of the innovation process and covering the whole innovation value chain. And for regulators to anticipate the regulatory challenges posed by innovations such as innovative nanomaterials (NMs) and nano-enabled products, their applications and potential safety issues. The report deals with ‘emerging risks’ of innovations in nanotechnology and nano-enabled products, with the challenge to make appropriate product development and risk assessment/ risk management decisions in the context of present uncertainties. These uncertainties can be reduced by using appropriate frameworks and the development and use of suitable OECD Test Guidelines. Thus, for the identification of potential emerging risks of NMs and nano-enabled products, there is the need to support the development of suitable Test Guidelines, as well as relevant risk assessment tools and frameworks for a Safe(r)Innovation Approach. This project, led by France (INERIS) and the Netherlands (RIVM), with the support of the European Union (Joint Research Centre of the European Commission), and Industry (Business and Industry Advisory Committee) as well as several other partners also benefited from lessons learnt from FP7 and H2020 projects such as NANoREG and NanoReg2.
