One of the greatest challenges facing regulators in the ever changing landscape of novel nano-materials is how to design and implement a regulatory process which is robust enough to deal with a rapidly diversifying system of manufactured nanomaterials (MNM) over time.
To address it, NanoReg2 is built around the challenge of coupling Safe by Design to the regulatory process, and seeks to demonstrate and establish new principles and ideas based on data from industrial value chain implementation studies so that Safe by Design can become a fundamental pillar in the discovery, screening and commercialisation of novel MNMs. So as to say, the challenge is to build a regulatory system, which incorporates the flexibility of keeping pace with innovation by allowing for continuing innovation within its own architecture.The credibility of such a regulatory system, underpinned by the implementation of Safe by Design combined with regulatory relevant Groupings principles, as part of the Safe Innovation Approach, is essential for Industry's ongoing innovation and competitiveness, as well as Industry's early involvement in the process, in order to implement regulation in a cost effective and rapid manner and ultimately strengthen the innovation potential.
The 6 main objectives of the project are :
Objective 1
Identify and define regulatory requirements, build safe-orientated grouping approaches linked with Intelligent Testing and non-testing strategies (ITS). “Grouping approaches” are well established for chemicals, for example through the identification of chemical categories (“category approach”) or analogues (“analogue approach”).
Build a global Intelligent non-Testing & Testing Strategies (ITS) designed for toxicological, eco-toxicological and physical hazards.
Objective 2
Identify and select materials as candidates for value chain demonstrators, develop life cycle maps and identify existing and potential exposure scenarios.
Objective 3
Evaluate the relative change in environmental and human health risk, following implementation of the SbD process (for occupational and product (consumers and environment) safety), estimate any residual risk following SbD and recommend additional risk mitigation/management measures as appropriate.
Objective 4
Develop and adapt supportive technical and organizational tools for Safe by Design, based on regulatory orientated grouping approaches. Based on grouping approaches placed in a general ITS, and based on a defined value chain, develop a comprehensive model supporting SbD principles to reduce uncertainties regarding safety along the value chain and therefore promoting safer innovations. This will be relevant when marketing should be balanced with competitiveness and social constraints.
Objective 5
Identify and overcome barriers to the application of SbD concepts, including development of approaches to adequately address such barriers, taking into consideration grouping approaches and Risk Management (RM) requirements, with a view to ultimately eliminate the barriers and provide examples of guidance towards achieving SbD.
Objective 6
Disseminate Safe by Design tools and SOPs, promoting regulatory orientated guidelines, define Public-private partnerships (PPP) such as helpdesk on SbD or such as pre-validation for nanosafety tools.
