Link to Safe Clause Samples

Link to Safe by-Design and Innovation chain (D6.3, D6.4)‌ One of the bottlenecks in the governance of new technologies is timely anticipation of regulators to secure that regulations cover all safety aspects of such a new technology. It is obvious that for MNMs and MNM containing products this has not been the case. To our opinion regulators were not enough and not timely aware of the innovative aspects of MNMs in order to realize that regulations and guidance were not adequate to regulate MNMs properly. Conceptually, approaches like Horizon Scannings and Foresight Studies could help to avoid such situations or at least could help to diminish the magnitude of the problem. In more practical terms, the link relies in the scope of the Safe by Design, which is in simple terms, to allow the integration of the potentials for health and environmental risks as early as possible in the innovation chain, for all the actors interacting in the value chain, including regulators. The NANoREG foresight system for innovation monitoring as designed in D6.1 can be applied a little before the early stage of the stage-gate approach, i.e. at the idea phase. Idea, in this case, means that there are some studies at lab scale that indicates that a given nanomaterial has certain properties useful in a given application (e.g. conductivity for consumer electronics), or there is the plan to test the specific nanomaterial more extensively on the basis of one single experiment to be applied in a set of applications. Therefore, the idea should be very innovative, at the Research stage with a low TRL, and with a medium term to market. In this case, if an industry, regulator or a decision maker have some concerns about the potential impacts of such application/s, and if the application/s is/are new and very few if even no safety data are available, the NANoREG foresight system for innovation monitoring approach can be applied to identify issues that need to be addressed early on. Also, the approach can support the comparative assessment of different R&D choices for a promising MNM on the basis of expected impacts. In summary, the NANoREG foresight system for innovation monitoring approach is ending when the Safe by Design is starting, but there is a certain degree of overlapping, since the information collected during the application of the D6.1 approach can be a starting point for the “idea” assessment in terms of safety.