The three pillars underpinning Safe by Design (Safe design, Safe production, and Safe use) and developed in NanoReg2 will be closely linked to the Stage Gate model:
Safe Innovation includes:
- Safe by design: from potential for risk towards demonstrators for (lack of) risk
- Regulatory preparedness: from sharing expertise towards guidance to prove safety
The 3 pillars will be developed within WP1, WP2 and WP4 and disseminated in WP6.
Pillar 1: Safe products by design
When dealing with Safety by Design (SbD), the first goal will be to try to achieve Safe Products, by design, meaning to find less hazardous nanoforms based on chemical and other properties. The development of very fast non-testing tools which do not involve the use of nanomaterials, combined with testing tools which do involve nanomaterials, could be an appropriate means to reach this objective by a gradually evolving effort and in a cost efficiency manner. This pillar will then combine non-testing tools such as Grouping strategy and prediction tools (Read Across, SAR, QSARs, QSPRs) defined in the NanoReg2 project, and testing tools such as High Throughput Screening, in-vitro models and in- vivo short term assays developed and validated in other projects and merged into an Intelligent non- Testing and testing Strategy in NanoReg2. This approach will then be able to quantify the enhancement of the safety of a MNM where uncertainty, costs and time frame of the result are linked through a funnel approach as shown in Figure . This approach should then be applied to both pristine materials and aged ones, in order to evaluate hazard evolution during the life cycle of the MNMs.
Pillar 2: Safe use of products
As safety is not only a matter of intrinsic hazard, Safe Use of a product should be addressed, aiming to evaluate the exposure risks on consumer and the environment in order to define reductions or mitigation actions and identify safe uses of a product. For this, the objective could be then to evaluate the risks during all uses capabilities in order to optimize of define acceptable uses. Examples could be the evaluation of the uses of MNMs having functional properties (eg. Biocides, mechanical) in different sectors (eg. Medical devices, textile, food...) in order to identify those minimising or avoiding exposure during the use or while recycling them. Building on the first pillar, when a product has been made as safe as is possible, this second pillar will facilitate an evaluation and determine any restrictions on the use of a specific nanomaterial. In this pillar we are then considering the Safe Use of products or materials. Pillar 2 will combine Life Cycle Studies defined in WP2, Cost/Benefit analyses defined in WP1 and WP2, and will be applied in WP4 case studies.
Pillar 3: Safe industrial production
When considering safety principles, we shall address not only the products and their use, but also the conditions of their production as workers and industrial environments are the first exposed groups. Safe industrial production therefore aims to give industries the knowledge and tools on risk assessment and industrial safety enhancement so that industry develops the capabilities to enhance safety in the workplace. It will also enable a better control on the industrial processes along the production chain, including storage and transport of MNMs. This pillar will develop the capability to give knowledge to industry through the training, and qualification (eg. certification schemes) of workers and Health and Safety departments. The production of SbD SOPs and standards, guidelines on Best Available Techniques for workplace safety, including equipment qualification and certification schemes and protocols will be addressed as relevant tools for promoting safety at the workplace. Specific links with public bodies able to help on request will also be addressed, aiming to give expertise on request (eg a HelpDesk) or to evaluate, validate or promote new tools addressing SbD (eg. a Private-Public Platform). All these instruments addressing safe industrial production will be developed in WP1, WP2 and WP6 and applied in WP4.