Research roadmap for nanosafety Part III: Closer to the market (CTTM)

Nano-products and nano-enabled applications need a clear and easy-to-follow human and environmental safety framework for the development along the innovation chain from initial idea to market and beyond that facilitates navigation through the complex regulatory and approval processes under which different product categories fall. The missing framework results in a lack of (i) solid data regarding roadblocks to market penetration of nano-enabled products as well as the absence of (ii) transparency in terms of which products (e.g. containing nanomaterials (NMs); nano-enabled products) are on the market (e.g. registries) and voluntary schemes and labelling requirements for cosmetics and food, which processes are used for manufacturing nano-enabled products, and (iii) meager inclusiveness in the dialogue (between all stakeholders) most likely exist as a result of the missing framework. The Closer-to-the-Market-Roadmap (abbrev. CTTM) aims at speeding up the progress towards market implementation of nanotechnologies by outlining the steps needed to develop such a framework. In its current form it is addressed towards policy makers, but the ultimate framework will be designed for use by SME and enterprise organisations.

The CTTM identifies the key challenges to be tackled immediately and outlines a stepby-step approach to establishing a framework to deliver of nano-enabled products to the market: (i) building an inclusive collaboration network, (ii) bringing together the scientific and entrepreneurial experts, (iii) strengthening dialogue of all stakeholders (inclusiveness!) and exchange to raise synergies and safe resources, (iv) implementing of a novel risk assessment framework supported by the regulatory initiatives and implemented by contract research organisations, and (v) building service provider platforms which function as consulting agencies assisting companies to bring their products towards market implementation.

Along these actions, the respective skillset development, educational training and formation of job profiles and recognition certificates shall be established. The accompanying tasks will be to continue the dialogue (e.g. risk communication, safety awareness, dissemination dialogue, needs assessment, debate on key topics, consultation on proposed activities/solutions, etc.) with different stakeholder groups (such as e.g. public authorities, broad public, opinion leaders, NGO´s, etc.) with the objective to increase the level of information via visualization and communication, in order to address all the current gaps listed within the CTTM. This will enable a transparent and open communication process.

Along with facilitating the market implementation of nano-products and nano-enabled applications, the consumers and end users of these products shall be provided with a clear and validated declaration regarding the use and function of NMs in products. Such information will show, in a balanced and standardized way the risks and benefits of the nano-enabled vs. the previously established products and of course addressing the unique new products and applications enabled by nanotechnology. This will increase understanding (and potentially support building trust) among stakeholders about safety issues, reduce the uncertainties for SMEs and enterprises about how to address the nanoenabled products (and NMs) properly, and minimise the impact of risk and safety assessment processes on hampering the innovation potential.

Following the recommendations of the EU REACH system (Article 13) and regarding ethical aspects, the risk assessment procedures should be performed with possible CTTM_NSC_Roadmap_final_for_NSC 7 reduction of living animals’ use. Whenever possible, alternative methods such as in vitro and in silico (computational) testing should be applied for replacing experiments with higher animals. Moreover, the use of computational modelling for supporting Safer-byDesign (SbD) and High Throughput Screening (HTS) might be an interesting option for the innovative industry, since it enables to extend the number of considered solutions without increasing costs.

The actions proposed in the CTTM will reduce the uncertainties for all stakeholders, increase the safety of nano-enabled products while reducing their time to market, and increase the market confidence in this technology and the acceptance of the safe nanoenabled products by businesses and consumers.