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. Not only does the complexity of the MNM present a problem for regulators, but the validity of data decreases with time, so the well-known principle of the half-life of facts means that what is an accepted truth now is no longer valid in 20 or 30 years.
The challenge was to build a regulatory system flexible enough to deal with new targets and requirements in the future through the development and introduction of Safe by Design (SbD) principles. The credibility of such a regulatory system, underpinned by the implementation of SbD, is essential for industry, who while accepting the need for regulation demand it is done in a cost-effective and rapid manner.
The NanoReg2 project, built around the challenge of coupling SbD to the regulatory process, demonstrated and established new principles and ideas based on data from value chain implementation studies to establish SbD as a fundamental pillar in the validation of a novel MNM. It is widely recognised by industries as well as by regulatory agencies that grouping strategies for NM were urgently needed. Grouping concepts developed by NanoReg2 can be regarded as a major innovation therefore as guidance documents on NM grouping will not only support industries or regulatory agencies but will also strongly support commercial launch of a new NM.
In this project, 42 organisations across more than 15 countries worked together for three years (end date February 2019) to create principles that underpin the next regulation generation.
NanoReg2 had an impact on the industry (safer products, fewer uncertainties, more cost-effective innovations), regulators (better preparation for new innovations in MNMs and related products), researchers (strengthening the research, development and innovation process through the Safe by Design concept) and society (transparent and traceable information on the safety of nanomaterials and related products). The results of the NanoReg2 were presented in a scientific paper.
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement 646221.
The Safe by Design concept aims to reduce potential health and environmental risks early in the innovation process. Such a concept aims at creating an integrated research strategy. This enables the consideration of safety aspects for humans and the environment in the design process of a product/material, to eliminate or minimise the risk of adverse effects during its life cycle including construction, use, maintenance and deconstruction. Within the Safe by Design concept the functionality of a nanomaterial and its toxicity/safety are therefore considered in an integrated way. Such an approach maximises resource use and expedites the development of products containing nanomaterials and new nanomaterials that are safer by design.
How can Safe by Design benefit you?
The SIA Toolbox is a set of tools, guidance and checklists to be used by innovators and regulators along the innovation chain. It supports both improved dealing with new safety issues of innovative nanomaterials and nanomaterial-containing products and improved regulatory preparedness.