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Christian Micheletti
Senior Consultant at TEMAS AG

OpenTox Euro 2019 workshop: Safe by Design concept and implementation regarding complex substances

The Safe by Design (SbD) concept for nanomaterials and nano-enabled products has been developed by TEMAS and others under different flagship European initiatives to cover uncertainties and risks regarding the nanosize [1]. The concept helps innovators to be prepared for regulation and regulators to be prepared for innovation; establishing transparency and trust between innovators, regulators, and consumers. The final goal being to design safer products, applying the precautionary principle, so uncertainties and risk can be identified and managed as early as possible. The SbD concept is based on regulatory requirements, but enables the user to work independently at each phase of an innovation and development project. To materialise this concept, the Safe by Design Implementation Pl atform was subsequently developed by TEMAS as a web-based management structure, to support industry working with nanomaterials and other relevant materials (eg advance materials) both in processes and product development. The final aim being that safer products arrive on the market in a cost-efficient manner, always taking into account hazard and exposure issues to workers, consumers and environment. The Platform is Regulatory driven and fed by both hard regulations (REACH, Occupational Health, Cosmetics, Biocides, Pesticides) and soft regulations [Life Cycle Assessment (LCA) and Socio-Economic Analysis (SEA)] anticipating future requirements, so users are better prepared for upcoming regulations in a cost-efficient way. The Platform can be used at different innovation processes and with different applications. Examples of how to use the Platform in different developmental settings and regulatory contexts will be provided within the “Safe by Design concept and implementation regarding complex substances (nanotechnologies as an example)” workshop. 

[1] Kraegeloh A, Suarez-Merino B, Sluijters T and Micheletti C Nanomaterials 2018 (8) 239